#Pharmaceutical Batching

[sgsystemsglobal]

Future Trends in Pharmaceutical Traceability Software: Innovations on the Horizon

The pharmaceutical industry is on the cusp of a digital transformation, with emerging technologies reshaping the way companies manage the safety, quality, and traceability of drugs. At the core of this evolution is pharmaceutical traceability software, which allows manufacturers to track and monitor the movement of products and raw materials across the entire supply chain. With growing regulatory demands and the need for better transparency, pharmaceutical companies must keep pace with innovations that enhance product safety and compliance.

In this blog, we’ll explore the future trends in pharmaceutical traceability software that are set to revolutionize the industry, enabling pharmaceutical companies to meet stringent compliance standards like 21 CFR Part 11, improve operational efficiency, and ensure the safety of their products.

Why Traceability in Pharmaceuticals Matters

Before diving into the future trends, it’s crucial to understand why pharmaceutical traceability is so essential. In the pharmaceutical industry, product safety and quality are paramount. Traceability ensures that every batch of drugs can be traced back to its source, from raw materials to the final product. This is not only important for ensuring the integrity of the product but also for managing recalls, reducing counterfeit drugs, and complying with global regulatory standards.

With regulations such as 21 CFR Part 11 Compliance, which governs the use of electronic records and signatures in the U.S. Food and Drug Administration (FDA) regulated industries, pharmaceutical companies are under pressure to implement robust traceability systems. Compliance with this regulation ensures that electronic records are trustworthy, reliable, and equivalent to paper records. Effective pharmaceutical traceability software is essential to achieving this.

Now, let’s look at the future trends that are shaping the next generation of pharmaceutical traceability.

1. Blockchain Technology for Immutable Records

One of the most exciting innovations on the horizon for pharmaceutical traceability software is the integration of blockchain technology. Blockchain’s ability to create a decentralized, immutable ledger makes it a perfect fit for industries that rely on highly accurate, tamper-proof data.

In the context of pharmaceutical traceability, blockchain can provide real-time visibility into the entire supply chain. From sourcing raw materials to tracking the distribution of the final product, every transaction is recorded in the blockchain, making it impossible to alter without leaving a trace. This level of security is particularly important for combating counterfeit drugs, which continue to be a significant issue in the industry.

Moreover, blockchain offers enhanced transparency and can help pharmaceutical companies demonstrate compliance with 21 CFR Part 11. By providing an indelible audit trail, it becomes easier to prove the integrity of electronic records, ensuring that all actions taken in the drug manufacturing and distribution process are traceable.

2. AI-Powered Predictive Analytics for Quality Control

As pharmaceutical batching and production processes become more complex, predictive analytics powered by artificial intelligence (AI) is becoming a critical component of traceability software. AI can analyze vast amounts of data in real-time, identifying patterns and trends that might indicate potential quality issues or inefficiencies in the supply chain.

For example, AI can monitor environmental conditions during drug manufacturing or shipping and predict when deviations might occur that could compromise product quality. This predictive capability allows pharmaceutical companies to address issues before they escalate, ensuring that only safe, high-quality drugs reach the market.

Additionally, AI-driven analytics can optimize pharmaceutical formulation software, which is responsible for ensuring that drug recipes are consistently followed. By analyzing data from previous batches, AI can suggest adjustments to formulations or processes to improve product consistency and quality.

3. IoT Integration for Real-Time Monitoring

The Internet of Things (IoT) is another technology that is poised to enhance pharmaceutical traceability. IoT devices, such as sensors and RFID tags, can provide real-time monitoring of pharmaceutical products as they move through the supply chain. These devices can track important parameters such as temperature, humidity, and location, ensuring that drugs are stored and transported under the right conditions.

For instance, biologics and other temperature-sensitive medications require strict temperature control during transportation and storage. IoT sensors can continuously monitor the temperature, providing real-time alerts if it goes outside the acceptable range. This ensures that any temperature excursions are immediately addressed, preventing potentially harmful products from reaching patients.

When combined with pharmaceutical traceability software, IoT data can be seamlessly integrated into the traceability system, offering a comprehensive view of the product’s journey from production to patient delivery. This not only enhances safety but also aids in regulatory compliance by providing detailed documentation for audits.

4. Enhanced Data Security and Privacy Features

As pharmaceutical companies increasingly rely on digital systems for traceability, data security and privacy are becoming critical concerns. With the rise in cyberattacks targeting healthcare and pharmaceutical companies, traceability systems must evolve to offer robust security features that protect sensitive data.

Future pharmaceutical traceability software will likely incorporate advanced encryption techniques, multi-factor authentication, and AI-driven security measures to detect and respond to potential threats in real-time. These features will ensure that all traceability data, including electronic records required for 21 CFR Part 11 compliance, are protected from unauthorized access or tampering.

In addition, data privacy regulations, such as the General Data Protection Regulation (GDPR) in Europe, place strict requirements on how companies handle personal data. Traceability software will need to incorporate tools that allow pharmaceutical companies to manage data privacy effectively, ensuring that any patient or product information is stored and transmitted securely.

5. Cloud-Based Traceability Solutions for Scalability and Flexibility

Cloud computing is set to play a significant role in the future of pharmaceutical traceability software. Cloud-based traceability solutions offer scalability, flexibility, and cost-efficiency, making them an attractive option for pharmaceutical companies of all sizes.

By leveraging cloud infrastructure, pharmaceutical manufacturers can scale their traceability systems as needed, accommodating growing production volumes or expanding into new markets. Cloud-based systems also offer the advantage of remote access, allowing teams across different locations to access traceability data in real-time.

Moreover, cloud solutions can streamline compliance with 21 CFR Part 11 by providing secure, centralized storage for electronic records and signatures. Cloud platforms are often equipped with advanced compliance features, such as automated audit trails and secure data backups, helping companies ensure that they meet regulatory requirements.

Conclusion

The future of pharmaceutical traceability software is bright, with innovations like blockchain, AI, IoT, enhanced data security, and cloud-based solutions set to transform the industry. These technologies will enable pharmaceutical companies to improve product safety, streamline compliance, and increase operational efficiency.

By adopting these cutting-edge technologies, companies can not only meet the ever-growing regulatory demands but also enhance the integrity of their supply chains, ensuring that patients receive safe and effective medications. As these trends continue to shape the future of pharmaceutical traceability, businesses must stay ahead of the curve to remain competitive and compliant in an increasingly complex global market.

[curiousquill1]

How VJ Instruments' Rapid Mixer Granulator Streamlines the Granulation Process

For pharmaceutical manufacturers and research facilities, it has always been a tightrope walk between getting consistent quality granules while not compromising on efficiency. The granulation process, of course, is critical for tablet manufacturing, often becoming the bottleneck in manufacture pipelines. This is where VJ Instruments' Rapid Mixer Granulator (RMG) comes into play, revolutionizing the approach to pharmaceutical granulation.

Understanding Modern Granulation Challenges

Pharmaceuticals are still being put to great tests in their granulation process:

Poor reproducibility of particle size

Long process times, which have a direct bearing on production time

High energy consumption, with difficult cleaning and maintenance procedures

Variable quality of end products

These challenges are not just about production times but directly affect the final product's quality and uniformity. This highlights the need to choose quality granulation equipment for pharmaceutical industries.

VJ Instruments: Engineering Excellence Meets Practicality

The VJ Instruments' Rapid Mixer Granulator stands out due to its innovative approach to design, overcoming pain points in granulation while introducing new efficiencies into the process.

Advanced Mixing

One of the core parts of the system is the three-zone mixing chamber, which includes:

Primary mixing zone with optimized blade geometry

Secondary zone of high shear for uniform particle size

Tertiary zone of homogenization for uniform distribution

This triple-zone design allows for complete mixing while protecting sensitive materials with delicate handling—a task that traditional equipment rarely accomplishes.

Intelligent Process Control System

The RMG comes equipped with:

Real-time monitoring of critical parameters

Automatic adjustments to mixing speeds

Accurate granulation end-point detection

Data logging to support batch consistency and regulatory compliance

Time-Saving Design Features

Innovative features of the RMG reduce processing times, such as:

Quick-release bowl design for easy and fast cleaning

Tool-less assembly and disassembly

Automated cleaning systems

Smooth and easy product transfer

Performance Metrics That Matter

The VJ Instruments RMG delivers measurable improvements:

40% reduction in granulation time compared to traditional methods

25% reduction in power consumption

99.9% batch-to-batch consistency

60% faster clean down between batches

Quality Assurance Built In

Every aspect of the RMG design focuses on product quality:

GMP-compliant materials

Proven cleaning procedures

Comprehensive documentation package

Control system compliant with 21 CFR Part 11

Practical Applications and Versatility

The system excels in a variety of applications, including:

Wet granulation for immediate-release tablets

Dry granulation for moisture-sensitive formulations

Multi-layer tablet preparation

Formulation processing of modified release formulations

Industry-Specific Adaptations

VJ Instruments offers custom solutions for:

Research and development laboratories

Pilot-scale manufacturing facilities

Full-scale manufacturing operations

Contract manufacturing organizations

ROI and Operational Benefits

Investing in VJ Instruments' RMG means actual savings:

Minimized labor costs through automation

Reduced material waste

Improved product quality

Increased capacity

Reduced maintenance

Sustainability Features

VJ Instruments prioritizes environmental awareness along with operational productivity:

Energy-saving motors and drives

Water-saving cleaning systems

Minimized waste generation

Recyclable component materials

Support and Service Excellence

VJ Instruments provides comprehensive support with:

Installation and commissioning support

Operator training programs

Preventive maintenance schedules

24/7 technical support

Regular software updates

New Equipment Transfer

Acquiring new equipment involves extensive planning. For VJ Instruments, here's what they provide:

Implementation roadmap with detailed analysis

Validation-support documentation

Process transfer assistance

Training materials and resources

Quality assurance protocols

The Future of Pharmaceutical Granulation

Despite changes in the pharmaceutical industry, VJ Instruments’ RMG is designed to face all challenges that the future may bring. Modular designs and easily upgradeable components make this product not only a solution for today but also an investment in tomorrow's manufacturing capabilities.

Need a Change in Your Granulation Process?

How can VJ Instruments' RMG Rapid Mixer Granulator optimize your pharmaceutical manufacturing operations? Contact our Technical Team for a FREE PERSONALIZED CONSULTATION and DEMONSTRATION on how our RMG can meet your specific production needs.

[processxe]

Unlocking Efficiency and Compliance with Electronic Batch Records

The requirement for simplified procedures and strong regulatory compliance has never been more crucial in the ever-changing environment of the manufacturing and pharmaceutical sectors. Electronic Batch Records (EBRs) arise as a game changer, revolutionizing how enterprises manage and document their manufacturing operations. In this blog, learning about what they are, how they work, and how they're changing the future of manufacturing. Development of Batch Records

Batch records were traditionally paper-based documentation that documented the phases of a manufacturing process. These records were not only difficult to handle, but they were also disposed to to mistakes, inefficiencies, and compliance problems. It was a difficult undertaking to keep these records up to date, retrieve past data, and ensure compliance with changing regulations. Electronic Batch Records: A Switchover

Introduction of Electronic Batch Records signaled a revolution in how industry managed their production operations. EBRs replace stacks of paper with digital records, which has various advantages.

EBRs remove the risk of human mistakes associated with manual data entry, resulting in increased accuracy and efficiency. Data gathering and validation methods that are automated ensure that information is correct and up to date. This results in fewer manufacturing mistakes, less waste, and more efficiency.

With EBRs, you can monitor manufacturing processes in real time. This not only allows for speedier decision-making but also gives significant insights into the manufacturing workflow. Managers can quickly identify bottlenecks and inefficiencies and implement remedial actions.

Compliance with industrial rules is of the utmost importance. EBRs make compliance easier by automatically recording each stage of the manufacturing process, ensuring that all necessary data is gathered and securely preserved. This makes audits and regulatory inspections easier.

EBRs make it simple to retrieve past data. This is extremely useful for tracking product quality, investigating issues, and continuously improving. It also makes it easier to generate batch-related reports.

Collaboration across teams in various places is frequent in today's globalized environment. EBRs provide remote access and collaboration, allowing teams to collaborate effortlessly regardless of their geographical location.

Implementing Electronic Batch Records

EBR implementation necessitates careful planning and technological investment. The following are important goals in the implementation process:

Choosing the Right Software: Select EBR software that meets the demands and regulatory standards of your sector. Scalability should be considered to support future expansion.

Training: Provide training to your workers to guarantee they can utilize the EBR system properly. This involves knowing how to enter data, monitor operations, and fix problems.

Transferring data from paper-based records is referred to as data migration.

Process XE is web based, flexible and user-friendly software solutions for Business process automation.

For more details on MES, Contact our sales team. <Book A Demo>

[loudlittleecho]

Too Late to Save Them: Frozen in Time

Previous

Part 4

Nathan was ecstatic. Somehow his dad had found this once in a million asteroid on the farm. It was ice, unmelting ice, and his dad was clueless on how to use it. 

Nathan knew how to use it. 

Quickly, he chipped down. It always grew back to its original size, so why not see how far it went?

. . . That. That was why.

Nathan put in parameters. Only so many inches to be chipped. GO NO FURTHER.

He didn’t want his workers, his investors, ANYONE to see what was in the center of the ice.

A child. 

Probably a meta. 

A black haired, pale blue, (hopefully) dead child whose body continuously created unmeltable ice. 

Ignore it. Create the company. Make millions. 

. . . 

Tim Drake-Wayne was dealing with a broken arm. Again. Bernard had been very sweet though, and asked him to check up on this company, saying that the company was “hiding something.” 

Tim figured it was Bernard's way to distract him, but. . . Bernard was right. Things weren’t adding up. 

Forever Ice. Started as an insulated cup company, but quickly went to pharmaceuticals. And jacked up their prices, citing its difficulty to produce and its limited quality per batch. 

Did Tim like this? Well, if Forever Ice did what it said it did, yes. But Tim believed in the saying: “If it’s too good to be true, it probably is.”

Tim did what he did best. Researched.

Forever Ice didn’t have a patent for their material. Well. They ‘did’, but Tim’s cursory glance recognized the bullshit inside the patent. 

He easily bought one of the cups, broke it (it specifically had a warning on it. To dispose if seal is broken) and checked the innards. 

Broken bits of the icy insulant were embedded in the double insulation, and was cool to the touch- COLD to the touch, even through his gloves.  

Tim carefully pulled a piece out and tested it. 

Whatever Forever Ice was, it wasn’t originally from earth. 

It’s cellular structure was. . . well, it wasn’t quite there. Even the bat computer couldn’t pick it up. 

Tim stretched in the computer chair. He may have been benched from crime-fighting, but no one said anything about good old detective work. 

- - -

Mrs. Freeze- Nora grimaced at the name. She needed to think of a better moniker. She was FREE. no more sick little Ballerina. No more frozen sickly wife. No more. 

Victor. . . she had loved him. They were happy. But when she got her diagnosis, Victor had started looking for a cure. Nora wanted to live the rest of her days happy. 

She had told him NO. 

She thought he had let it go. . . 

But their last dinner together, before she woke up as. . . this. . . 

He had drugged her meal. She had been aware enough to watch him gently hold her face and promise her. He would find a cure. 

He brought her to that horrible machine.

Victor had found a cure. It made her like HIM. Requiring a sub-zero temperature suit to live. 

And after he cured her, he wanted them to retire! He had LIVED. She had been suspended. Frozen in time. Before, he’d been two years older than her. But now decades of life had passed her by in that cursed cryo chamber.

Victor had lived, and changed, and aged. 

Nora hadn’t. 

And apparently during her frozen slumber, Victor had gotten an idealized version of her in his head. 

The Real Nora and the idyllic Nora had some similarities: Ballerina. Wife. Illness. Loving Victor. But they were different. Nora was a ballerina, yes. But that wasn’t her only interest. She was a wife, but she was also a daughter. A friend. An enjoyer of pasta. She had been sick. But she had a life! She had been given a timeline, and she had made a list of things she had wanted to do. She wanted to LIVE with the time given to her. And she had loved Victor. But the two of them weren’t perfect. They had their good days, and their not so good days. They worked through their communication and she had hoped to grow old with him. Before the diagnosis they had thought of. . . 

The past was the past. 

She had woken up, and she had been angry. Confused. The man in front of her didn’t look like Victor, but sounded like him. He was blue. She would be too. They needed money.

He gave her a weapon and taught her how to fire. How to fight.

This wasn’t the Victor she remembered. 

She followed him along, and as they went on their “crime spree”, she began to feel ALIVE again. 

And then Victor said they didn’t need to do this anymore, that it was time to retire. Time to find a sweet little place to enjoy the rest of their lives together. 

She argued back.

He told her she wasn’t thinking straight. It must be something with the formula. But not to worry, he would fix her.

NO.

Nora didn’t think it was the formula. She was angry, and she had a RIGHT TO BE!

Victor hadn’t understood. He wanted to make her pliant. submissive. Into the Idyllic Nora.

She shook herself out of her memories. It was over. 

She wasn’t proud of herself, but she had harmed Victor. To her, it was the only way. 

He had proven himself in the past that he would take away her autonomy. 

It was the only way to be free.

. . . 

Nora wasn’t a scientist, but she wasn’t stupid. The suit Victor had made for her wasn’t self-sustaining and she wasn’t going back to his workshop.

Not while that. . . Batman was around. 

But while she was in hiding, she had heard of this Forever Ice. 

Perhaps she’d stolen someone’s thermos. Tested it out. 

She would be able to replace the bits of her suit with this Ice and then finally, be truly, honestly, free. 

Able to make her own decisions. Be freed of Victor. Self-Reliant.

She just needed more.

Part 5

[titleleaf]

very curious about any dune perfume thoughts you may have

DUNE PERFUME THOUGHTS...

I feel like with all of Ferbert's tropes around effeminate overly-refined decadence there \_really_ needs to be more perfume action among the houses of the Landsraad, even if for no other reason than conspicuous consumption? The olfactive aspect of spice isn't really centered since its other psychoactive/pharmaceutical merits are more valued, but I've been really curious about the mechanism by which spice is ingested, if everybody's either eating it with their food or drinking it in solution or what. (Or, I guess, floating around in it.) Mentally I guess I'd been picturing spice more like an incense resin than an actual spice, but there's no textual justification or actual reason for that other than really liking incense.

Paul and Jessica both seem especially attuned to scent in the first book, linking it to poison detection but also to the presence of spice, which is probably smart when you're backpacking across Arrakis trying not to get blown up or space stabbed. Spice melange in the raw smells like cinnamon, pre-spice mass has a “rank, semisweet" odor, the Baron's private conference room carries a “faint sweet herb scent that hung on the air, masking a deeper musk”... lot going on in there! Idk if we’re supposed to assume it’s a human body-type musk derived from the Baron’s libertinage, something from the furnishings, or a fragrance element, but I really love the idea of this kind of uncomfortably exquisite sensory space. (And then Piter smells like squeaky latex gloves.) Per the Dune Encyclopedia, there's one fragrant drug whose whole mechanism of action is making you think it smells really really good:

PLENISCENTA (Rosa osymyrrah), the "Green Perfume Flower," is a small, delicate shrub with variegated leaves: the blooms are a brilliant emerald green and, when taken from Ecaz and sterilized, decompose with a most exquisite smell. Pleniscenta perfume has a benign psychomimetic effect: it overwhelms the olfactory nerves and causes localized synaptic responses which the brain interprets as indescribably pleasurable smells.

(Pleniscenta is also one of the flowering plants in the conservatory on Arrakis.)

The other big perfume culture question I have wrt the world of Dune/the various cultures represented in Dune is: what's the alcohol situation???? Social drinking isn’t the only determinant of alcohol based perfumery vs oil based (and there are lots of historical ways of incorporating scent that aren’t either one, which I would love to see incorporated into the corporate-feudal future of Dune) but it would be fun to explore different cultural uses of fragrance in that context.

For character-specific scents, oh this is so tough… there’s a big cast and a lot of high class weirdos to be represented but I think Etat Libre d’Orange has some fun scents for House Atreides. The Baron and Feyd are both pleasantly scented in ways that fall right into the same vein of weird stereotypes that House Harkonnen does (so, spicy resiny ambery scents some long-dead French guy decided reminded him of The Orient(tm), that well known cultural monolith????) but I think Piter’s scentscape would need to be made by a brand that specializes in really sterile chemical smells like Xyrena’s theme park bromine notes. (Not that he smells like a theme park dark ride, just that kind of “not existing in nature in any way” thing.) For Arrakis and Fremen characters I would want to go in the opposite direction and explore small-batch natural perfumery. I don’t own a damn thing from For Strange Women etc. because of the cost but I would want to seek out an indie natural brand that draws from desert botanicals (maybe some uncommon animal ingredients like hyrax? Rock hyraxes 🤝 sandworms) and wildcrafting, thinking of all the space ecology at work and the super sophisticated scarcity-minded tech the Fremen employ in that. And the Bene Gesserit are sexy liturgical incense girlies, ofc.

[marshmallowprotection]

The scene in the secret ending where the doctors are reading off the elixir ingredients is so insane to me. You’re telling me this whole time Saeran was on MUSHROOMS? METHANOL?? PEYOTE CACTUS???

Yeah, and those are only the ingredients that we know about. The elixir is a pure cocktail of drugs. These are the only ingredients that are mentioned to us by name.

I imagine the list of what is being pumped into it is never the same and I know that is true for a damn fact, anon. The formula is never the same because they make it in large batches with whatever they can get their hands on. That is revealed in Another Story by Ray himself. He knows the formula, and not only that, he is able to make something that looks exactly like it and relatively tastes close enough that nobody would say a word about it in a desperate situation.

It wouldn't surprise me in the slightest if they not only develop new batches but they test it on believers that are being cleansed. I mean, there's really only one surefire way to figure out what happens to the people who take it. You have to physically test it on people and nobody's going to be willing to do that. One of the first people to suffer through the elixir is Saeran himself. He wasn't the first person but he was one of the first to be inducted in that way.

Not only is he taking medication that is never in the same concentration all the time, he was a guinea pig for it in the first place. The sad reality in his after ending when he isn't affected by the elixir at all like everybody else is due to his tolerance that he's built up to the sheer overwhelming concentration. Like, we don't even know all of the ingredients in the elixir but what we do know lets us know how harsh it is for your body. Rika knows a lot of information about "herbs". She put it to use in the name of experimentation.

Let's not even try to figure out how she was capable of manipulating people during her time in the RFA to not only gain the financial backing for this process but how she made connections with the right people in the pharmaceutical industry. That would have taken a lot of work because she's not doing that by herself.

[the-silver-chronicles]

Music Monday + "What Are You Doing Here?" Quiz

Tagged by @g0dspeeed and @inafieldofdaisies

Tagging @socially-awkward-skeleton @direwombat @derelictheretic @shallow-gravy @strangefable @strafethesesinners @josephslittledeputy @purplehairsecretlair @deputyash @afarcryfrommymain @depyotee @voidika @onehornedbeast @softtidesworld @snake-in-the-garden @nightbloodbix @adelaidedrubman @wrathfulrook @chazz-anova @cassietrn @jacobmybeloved @henbased @carlosoliveiraa @ladyoriza @minilev @vasiktomis @neverthesameneveranother @thewanderer-000 @corvosattano and @vampireninjabunnies-blog

Here's three songs for my other Far Cry The Silver Chronicles stories, known as the following; Call To Arms duology starring Nadi Sinclair, Ain't It A Joy? staring Alexander Khaos and finally No One's Safe At Home starring Gavin Turquoise. The Quiz will be for an OC who appears in A Radioactive Calamity of Love, Bombs & Gore (a Fallout fanfic series). The quiz can be found here.

The Call To Arms fanfic duology of the Call Of Duty Modern Warfare games (at least only one and two, both taking elements from the original and reboot) starring Nadi Sinclair, a sharpshooter and recon for Task Force 141, fighting off terrorists like Makarov alongside her brothers (and sisters) from other misses and misters. This will only be a few years before she eventually leaves and joins the Project at Eden's Gate in Montana, Hope County.

"Come on

Come on, people Stand tall for the beast of America Lay down like a naked dead body Keep it real for the people workin' overtime They can't stay livin' off the government's dime

Stand tall for the people of America Stand tall for the man next door We are free in the land of America We ain't goin' down like this, come on, now

Come on, people Come on, people Come on, people Ha!

Come on, people Come on, people Come on, people Ha!

I will be right to you I will be right to you I will be right to you And together we can stand up to the beast."

Ain't It A Joy? is a modern-ish fanfic adaption of the We Happy Few game, starring Alexander Khaos as the main protagonist, as he finds out the lies behind Wellington Wells, the self-proclaimed happiest city of England which is closed from the rest of the country, is in fact nothing more than a cult stuck in a perpetual state of drugged bliss with the inhabitants believing they're clean of atrocities and stuck in a 1940s/60s mindset while being taken advantage of by a pharmaceutical tycoon, Crawford Klaus, as he replays old videos of a TV personality named "Uncle Jack" and supplies the next batches of "Joy"... and the newest variant called "Glee".

"A brilliant day is dawning A million smiles are forming Our shimmering isles are all enthralled No, there's nothing like conforming

Perish the thought of mourning Did you ignore the warnings? All negative thoughts abhorred "My Lord! Did you take your Joy this morning?"

Ask anybody in Wellington Wells They'll tell you it's terribly swell Delirious denizens swell where there's nary a speck between heaven and hell

They say that the empire fell "Oh, but you never could tell!" You say you remember it well? "You'd better forget it or else!"

Why try to better yourself? Reach for the medical shelf Just take your medicine, death and the pestilence melt into pleasant locales

Another rebellion quelled Dust off your suspenders and belts It's horrendous to dwell, so remember how splendid it felt to surrender yourself The roses we grow have a terrible smell

It's a Joy! It's a Joy (it's a Joy) It's a Joy (it's a Joy) To be among we happy few It's a Joy It's a Joy (it's a Joy) It's a Joy (it's a Joy)!"

No One's Safe At Home is a fanfic set in the Welcome To The Game universe, where the inner circles of "the Ministry" run their illegal activities behind the dark web as it reigns at the top, with constant murder, kidnappings, trafficking of all kinds and the most vile corruption persist in a world where morals are a joke. Until Gavin Turquoise starts going to great lengths in his intent on wiping their repulsive stain out of society and rigging the Game in his favor. In his crusade, he finds a strange child with... the most abnormal abilities. I can't help but laugh at the irony that this feared vigilante eventually becomes a lawyer in Hope County, being a bane to the Project at Eden's Gate and John Seed's existence.

"As Property Manager, my job is sorting the utilities Disposal of the garbage and the laundering facilities Why would I compile a full report on your activities? I'm just a standard landlord, "Glory to the Ministry"

Lock the doors and close the curtains, hold your breath lest you should speak your sins But you can't keep a secret from the building that you keep it in Befriend your fellow tenants, show a smile and keep it pleasant But know everyone's a friend until you need to turn some people in It's the breathing on the phone, hiding just beneath the tone It's the things that shift when no one's home Well, you may be on your own, but you'll never be alone Yes, we all live here, but it's no one's home

("They're here!")

To get through the day It behoves you to play by the rules and behave Do the state preapprove all the tunes that you play? When alone in a room, well, to whom do you pray?

Assume that your neighbours are moving away When the black van comes in the night And you're numb to the sight Of another fumbling for somewhere to hide As their wife just runs for their life 'Fore the ones with the guns can arrives And they're gone 'fore the Sun can arise To a government provided bunker for some realignment It's just fine, you can trust it's a wonderful time

Just go about your business normally No one's following, I'm not recording Your paranoia is awfully boring According to all of your friends that talk to me

Most importantly, please speak clear when you're broadcasting Your honest thoughts on the law or economy My provided mics are tiny And I can't transcribe properly Should you ever behold Me with my peepers pressed to a keyhole You can trust I'm just checking the tumblers for rust I'm a custodian, not a Ministry mole

Settle in for a night on the couch No questioning what that red light is about Now bleeping on your ceiling since the time you were out It's just a little gaslighting, put aside any doubts

You're fine in your house, so you confide to your spouse any crimes carried out Any tiny amount of new ideas found just a mite out of bounds 'Cause I'm writing them down in a timestamped account

What's it matter, every night or two? If I sneak in, have a rifle through? But depending what I find, well, You'll be faced with another kind of rifle, too

Privacy is the cry of the defiant to compliancy But grease my palm and I might not see Those books they banned from the libraries What do you mean, that's not yours? It appeared one night in your cabinet drawers? I have to report it, I regret But, of course, I could forget

Societal ideals are reliably pliable So the rise of a tyrant becomes entirely viable You will find that the spying is really quite justifiable Why are you crying when it's your blind eye that's liable?

Handy landlord here to fix your ventilation whistling Too many questions and it's not the air that needs conditioning That telephone's not tampered with Of course it isn't listening But were it, it prefers the words: "Glory to the Ministry!"

And last the results from the quiz! From my character:

Ortega "Ore" Brantley (A Radioactive Calamity of Love, Bombs & Gore, a Fallout fanfic series)

Ore has this "hope" that he carries with him. Despite the Wasteland he walks in, just as his sister Ress does, unlike her and their father, he can't help but focus on the beauty that has thrived even after the destruction. He's no fool, the world he lives in is dangerous, and as powerful as he is being a half-human, half-magical-creature-from-another-dimension, there are beings like his father, Arcane Urias, and his lackeys, like Aggravor, who can and will kill him if given the opportunity. Ress is hopeful... hopeful that with his efforts, the Wasteland can heal. That the people he's bonded with can live long content lives. That his sister can appreciate the lives of who she views as "weak" and see the strength these folks have despite the disadvantage they have against the likes of the Super Mutants, Synths and the Occult Urias founded. To see the responsibility to protect these people that they as the "strong" must carry. He hoped he could have seen the day where him, his sister and their companions could just lay down underneath the blue sky one day and just share with each other without the burden of death and destruction hovering over them in a moment of peace. Though he himself never lives to achieve this vision, he at least was glad to look at his sister and reassure her one last time before Aggravor's curse cut his long life short.

[iatrophilosophos]

"regulation means criminalization means punishing people for expressing autonomy" If you consider poisoning diabetic people with substandard insulin 'an expression of personal autonomy,' then youve completely lost the plot, and I would consider their families killing you in vengeance to be their turn of 'expressing autonomy'

...you do realize I'm talking about disabled people making medicine for themselves and their friends and family, as a prediabetic person, right?

I'm very sorry that the western medical industrial complex has taught you that people receiving medicine inherently have no choice in the matter and that you can't even conceptualize a world where disabled ppl have agency around what they put in their bodies but like...come on.

P sure releasing huge lots of tainted medication and causing massive harm is...what pharmaceutical companies do now 🙃🙃 y'know given the number of recalls that have happened this year alone. So, not exactly a problem with regulation is it? Most of these recalls r also related to issues with megascale production; contamination that gets missed in large batches made in huge factory spaces; problems with shipping and storage that leads to spoilage etc...not really the same kind of concerns we might have about small scale production.

Also again: tell me how insulin gets made and what the actual, precise risks involved are and then we can talk bc right now afaik you're just handwringing about a problem you made up. Maybe start with reading about openinsulin's work?

[bighermie]

BOMBSHELL: Spokesperson Admits During Australian Senate Hearing that Pfizer Employees Were Given Special Batch of Vaccine, Different from What was Distributed to Public (VIDEO) | The Gateway Pundit | by Jim Hᴏft

[plaindangan]

How did Seiko find out about Byakuya being Makoto's Sugar Daddy? And how much did she have to beg to also be one of his sugar babies?~

Disclaimer: R18 material! If not to your liking then please do not view!

"W-w-well, for the first...it'd be hard not to notice..." she mumbled, face scarlet in arousal as she recalled the scene, all while taking in the absurd lewdness of this present one.

She had walked into the Togami Conglomerate mansion and was escorted to a meeting room in order to give her 'pitch' as to why Seiko should be chosen to get his funding in order to use it for her pharmaceutical company...

And the first thing she saw was Makoto getting his plump, femboy ass, stretched out by Byakuya. The affluent progeny was fucking him both in a fierce, but professional manner.

Looking at Seiko, the heir only said one word that had so much weight even in this oddity.

"Proceed."

At that, Seiko began to stammer and rattle off why drugs she produced were a boon. How her's was the only way to give people such a quick bulk up. How her truth serum was second to none in quickness. How she can even cure the deadliest of poison!!! All of that genuinely interested Byakuya, but he became curious about another drug she had yet to show off.

At that, realizing she brought in one of her private batches, she tried to sway him not to take it, but he insisted sternly that she not only explain what it was...she'd give it to him. With his mind dead set, Seiko explained that it was a libido booster, and given how Byakuya still fucking the daylights out of Makoto - he just had to try out for himself!!!

Something that lead to Seiko's current situation~

PLAP! PLAP! PLAP! PLAP! PLAP!

"Yesssss....yeessssssss!!! I'll take it!!! I'll TAKE IT ALL!!!" Byakuya said fiercely, voice guttural in dominance. That libido booster not only had him left Makoto into full nelson, but it girthed up and pushed his big cock into relentlessly fucking Makoto, who was like a groaning zombie at this point, into full submission...for the next half hour or so~

All while Seiko quietly watched in awe. Well, watched and get on with massaging herself (gloved hands slipping into her panties and under her bra) with quite the bit of intensity. Normally, she wouldn't dare do this, but with how hard and fixated Byakuya was on fucking Makoto, surely he would never notice-

"You."

!!!!

NEVERMIND!!!!!! She immediately stopped, looking quite shocked he dared to look in her way and very much regretful of her perverted life choices.

"I-I'M SO SO SORRRY, I-"

"Nevermind that...you gave me such a wonderful new tool. But..." Gently, he place Makoto onto the table. Completely mindbroken and cock filled with Byakuya's cream. All while pointing his big, throbbing, fuckstick right at the geekish newcomer!!!

"...I have need for someone to get this out of my system. Assist me with this, and not just your company will reap the benefits. Understood?~" he asked, even though it sounded more like an order out of habit....

".......Come here, you big fucking boy!!!" she said, voice low and equally as horny even if she hadn't even even taking the serum yet!!! Pouncing up to Byakuya's table, she chugged down the rest of her libido boosting drug and then leapt onto the heir's body to give him a passionate kiss on the lips...all while her own fat ass lowered itself onto his high status cock~

By the end of it, not only was Seiko like Makoto - a sweaty, mindbroken, slimed over messed - but even the entire meeting room stunk of fierce lovemaking for the next month and a half...

A perfect initiation for another of Byakuya Togami's harem~

[sgsystemsglobal]

The Critical Role of Pharmaceutical Batching in Ensuring Product Quality and Compliance

Pharmaceutical batching is a fundamental process in the manufacturing of pharmaceutical products. It involves the precise mixing and production of specific quantities of ingredients to create a consistent and high-quality product. This process is crucial for maintaining the efficacy, safety, and regulatory compliance of pharmaceutical products. In this blog, we will explore the importance of pharmaceutical batching, its key components, the challenges faced during the process, and best practices for ensuring optimal outcomes.

Understanding Pharmaceutical Batching

Pharmaceutical batching refers to the process of producing a specific quantity or "batch" of a pharmaceutical product under defined conditions. Each batch must meet stringent quality standards to ensure that the final product is safe, effective, and consistent with regulatory requirements. The batching process typically includes the precise weighing, measuring, and blending of raw materials, followed by mixing, granulation, drying, compression, and coating, depending on the type of product being manufactured.

Key Components of Pharmaceutical Batching

Raw Material Handling

The first step in pharmaceutical batching is the accurate handling and measurement of raw materials. These materials must be of the highest quality and must meet predefined specifications. The accuracy of measurements is critical, as even slight deviations can affect the quality and safety of the final product.

Weighing and Dispensing

Weighing and dispensing involve the precise measurement of raw materials to ensure that each batch contains the correct proportions of active pharmaceutical ingredients (APIs) and excipients. Automated systems are often used to minimize human error and ensure consistency across batches.

Mixing and Blending

Once the raw materials are measured, they are mixed and blended to achieve a homogeneous mixture. This step is crucial for ensuring that the active ingredients are evenly distributed throughout the batch. The mixing process must be carefully controlled to prevent segregation and ensure uniformity.

Granulation

In many cases, the blended mixture undergoes granulation, where the powder is converted into granules. Granulation improves the flowability and compressibility of the material, making it easier to process during tablet compression or capsule filling.

Drying

After granulation, the material is dried to remove excess moisture, which can affect the stability and shelf life of the final product. Drying conditions, such as temperature and time, must be carefully controlled to avoid degradation of the active ingredients.

Compression or Encapsulation

The dried granules are then compressed into tablets or filled into capsules. This step requires precise control over compression force and tablet weight to ensure that each dosage form contains the correct amount of active ingredient.

Coating

Many pharmaceutical products are coated to improve their appearance, taste, and stability. The coating process must be carefully monitored to ensure uniform coverage and to avoid issues such as cracking or peeling.

The Importance of Pharmaceutical Batching

Product Consistency

One of the primary goals of pharmaceutical batching is to ensure that each batch of product is consistent in terms of quality, potency, and performance. Consistency is critical for maintaining the therapeutic efficacy of the product and ensuring patient safety.

Regulatory Compliance

Pharmaceutical manufacturers must comply with stringent regulatory requirements, such as Good Manufacturing Practices (GMP), which mandate the precise control and documentation of all manufacturing processes, including batching. Non-compliance can result in product recalls, fines, and damage to the company’s reputation.

Quality Assurance

Pharmaceutical batching is a key component of the overall quality assurance process. By carefully controlling each step of the batching process, manufacturers can identify and address potential quality issues before they affect the final product.

Cost Efficiency

Efficient batching processes can reduce waste, minimize production costs, and increase overall efficiency. This is particularly important in the pharmaceutical industry, where the cost of raw materials and production can be significant.

Challenges in Pharmaceutical Batching

Scale-Up from R&D to Production

Scaling up from small-scale research and development (R&D) batches to full-scale production can be challenging. Differences in equipment, environmental conditions, and raw material sources can affect the consistency and quality of the final product.

Equipment Calibration and Maintenance

Precise measurements and controls are critical in pharmaceutical batching. Equipment used in the process must be regularly calibrated and maintained to ensure accuracy and prevent deviations that could impact product quality.

Material Variability

Variability in raw materials, such as differences in particle size, moisture content, and purity, can affect the consistency and performance of the final product. Manufacturers must have stringent quality control measures in place to manage material variability.

Environmental Controls

Environmental factors, such as temperature, humidity, and air quality, can influence the batching process. Manufacturers must carefully monitor and control these conditions to ensure consistent product quality.

Documentation and Traceability

Thorough documentation and traceability are essential for ensuring compliance with regulatory requirements. Every step of the batching process must be documented, and records must be maintained to demonstrate that the product was manufactured according to approved procedures.

Best Practices for Pharmaceutical Batching

Implement Robust Quality Control Systems

Establish comprehensive quality control systems that monitor each step of the batching process. This includes regular testing of raw materials, in-process checks, and final product testing to ensure that each batch meets quality standards.

Automate Where Possible

Automation can reduce the risk of human error and improve consistency in the batching process. Automated systems for weighing, dispensing, mixing, and monitoring can enhance precision and efficiency.

Train Personnel Thoroughly

Ensure that all personnel involved in the batching process are thoroughly trained in GMP and the specific procedures used in your facility. Regular training updates should be provided to keep staff informed of any changes in procedures or regulations.

Conduct Regular Equipment Maintenance

Regularly calibrate and maintain all equipment used in the batching process to ensure accuracy and reliability. Implement a preventive maintenance schedule to minimize the risk of equipment failures that could disrupt production.

Focus on Documentation and Traceability

Maintain detailed records of every batch, including raw material sources, process conditions, and quality control results. This documentation is essential for demonstrating compliance and facilitating traceability in the event of a product recall.

Conclusion

Pharmaceutical batching is a critical process that directly impacts the quality, safety, and efficacy of pharmaceutical products. By implementing best practices, such as robust quality control systems, automation, and thorough training, manufacturers can ensure consistent product quality and maintain compliance with regulatory requirements. As the pharmaceutical industry continues to evolve, companies that prioritize precision and consistency in their batching processes will be better positioned to succeed in an increasingly competitive and regulated environment.

[lasseling]

Top Study Confirms Pfizer Pushed ‘Bad Batches’ of Covid Shots onto Public

A major study by leading Scandinavian researchers has confirmed that Pfizer distributed dangerous “bad batches” of the pharmaceutical giant’s Covid mRNA shots for public use.

[writingisawildride]

Hello

I know I'm barely here anymore

But unfortunately the Ritalin shortage in Summer caused me to become hyperfixation on Overwatch, Gabriel Reyes/Reaper in particular (AGAIN), against my very will.

But I'm here to make it everyone else's problem again and have been challenged by @wildissylupus to post my Martina Reyes HCs (or basically character summary at this point)!!!

So

Here

We

GOOOOOO

(Please note I am Filipina, not Mexican or Latine at all, I'm trying my best to research, but please correct me if I'm wrong)

- 1st of all, for me it is Dr. Martina Nuñez-Reyes, women in STEM, iconic

- Born and raised in San Diego, in particular in or by Barrio Logan!

- She is specifically Nahua Mexican with family in Guerrero, Mexico. She has learned a lot of Precolonial History and mythology, both in school and from her family. She also speaks Nahuatl fluently, as well as Spanish and ASL.

- Sweet, nurturing, professional, good tempered, graceful, makes lots of bad puns (she and Winston got along great), but occasionally slips in some "joking" sadism and morbid curiosity.

- Loves perfume even though she can't wear it often due to her work in laboratories and hospitals, will wear even just a little bit even at home to enjoy it.

- joined a ballet folklorico troupe up until High School, but still remembers the moves well. Specializes in Guerrero style folklorico!

- Excellent cook, amazing baker. Loves to adapt recipes to include lots of spices. (This will come back later)

- Interested in the medical field, specifically medicine itself, after learning about how advanced Mesoamerican civilizations were medically.

- Martina was a regular prodigy, attending an advanced secondary school academy in Mexico City, before continuing on to get PhDs in Medicine, Chemistry, and Pharmaceutical Science by age 24.

- By age 26 she had already made strides by synthesizing and creating medicine that was able to do things like naturally accelerate healing in the body.

- That's also when the Omnic Crisis began. She was inducted by the United States Military among swathes of other skilled doctors to create the Super Soldier Serum for the Soldier Enhancement Program (SEP) at a hidden facility.

- Six months, they managed to get it to an acceptable loss rate of 25%, and test it on 100 Soldiers. She was in charge of overseeing the injections of 20 of the 100 randomly assigned under her, which included Soldier 24, Gabriel Reyes, and Soldier 76, Jack Morrison. It was also done in doses, not all at once.

- She and Gabriel were attracted to each other but didn't act on it for quite a bit, due to the taboo nature of a doctor and a patient. They didn't flirt either, but had moments of "Oh fuck they're hot" before shaking it off.

- After the second round of doses, she lost her first soldier, which made the risk of SEP all the more apparent to her.

- Remember when I mentioned she's good at baking? She stress bakes because it helps make a zen sort of ritual of following steps/regaining a small sense of control. The reason Gabriel loves cookies? It's because he woke up at 2AM catching her stress baking a batch of Chili Chocolate Chip Cookies. It's where they had a heart to heart about Gabriel and the other Enhanced Soldiers trusting Martina and the doctors no matter the risk because they know they're liable to die in the Crisis anyway if they can't make headway.

- As the Crisis gets more dire, the General orders the doctors at the SEP facility to also go through basic military training, which Martina disliked, so she never really went past a machine pistol.

- 33 Soldiers make it out, and she sent with them on missions to retake cities across America. She wouldn't always be an active combatant, but she could hold her own if she had to.

- When Gabriel Reyes and Jack Morrison were selected to the elite Overwatch core team, she helped lead their medical support team. Also yes during this whole time, Gabriel and Martina still were attracted to each other but still sort of afraid to act because not only is she still his Doctor, he's now her commanding officer.

- Also during this period she helps treat a young Angela Ziegler during the bombing of Zurich.

- After fighting alongside Inti Warriors (Specifically Illari's dad) to help retake part of Central and South America, Gabriel almost died, which caused her to go full BAMF, and save him.

(Jack: "... can someone please tell me why our medic is rushing in alone, guns blazing?")

- They have to repair ships and stuff, so they decide to take R&R in reclaimed Guerrero, where Martina shows Gabriel around, and they end up dancing together. It's where they finally give in and end up in a relationship.

- Get married the last year of the Omnic Crisis, and have a son a few years later named Izel (who is the grown man with a family in my heart and soul in the Reflections Comic)

- Dr. Martina Nuñez-Reyes is the first Head of Medicine in Overwatch's Golden Age because goddamnit someone had to have that position before Angela.

- She's also Angela's mentor and sort of like an adoptive mom, Angela absolutely idolized her

Here's where my Canon deviates hard, because Blizzard's timeline makes no sense

(Fun fact this next part exists because I misread Code of Violence and thought that the ash and burning was from Gabriel's memories of Echo Park and not where he was so I straight up thought Martina was fridged a whole ass year before I heard the voicelines and reread it for clarity, but she's not fridged. Just stay with me.)

- On Izel's 6th birthday in Echo Park, there was an attempted assassination via explosions that caused Izel to lose his left arm and replace it with a prosthetic (the man in the Reflections comic has his left arm in his pocket)

- It also very nearly kills Martina, who is 6 MONTHS PREGNANT WITH THEIR DAUGHTER, Graciela

- The family lives, and Graciela has to be c-section delivered prematurely

- This ofc enrages Martina and Gabriel who, after recovery, hunt the motherfucker down to kill.

- It is not a quick death. Martina synthesizes POISON to make that fucker die screaming. (Basically I wanted to flip the Dead Wife trope where the wife lives and is FUCKING PISSED AND JOINS HER HUSBAND ON A ROARING RAMPAGE OF REVENGE)

- Oh yeah and that triggers the birth of Blackwatch lmao.

- Gabriel brought Cole Cassidy home for Christmas where she immediately enfolds Cole into the family.

- Martina and Gabriel also help Cole get his GED.

- Oh yeah Blackwatch

- So Martina supplies the poisons for coercion, torture, and assassination (and torture) to Blackwatch under the table for super covert missions, basically even people at Blackwatch didn't even know about. Ma'am was committing war crimes to keep the world and her babies safe. All while keeping up the sweet, dedicated, professional facade for like 14 years.

- Gabriel tries to get her to make another super soldier serum so he can be stronger, she refuses, they argue, him calling her a hypocrite, and it looks bad, UNTIL

- Shit happens and she accidentally lets a poison slip that gets reverse engineered and kills a lot of people, causing her to retire and Mercy steps up. Gabriel keeps her secret and they end up staying together

- HOWEVER, once the Venice Incident happens and Izel disowns his father, she chooses to not back up Gabriel's choices, whereas their daughter Graciela does, causing them to be separated but still married.

- Gabriel considers leaking her secret, but loves her too much to/wants the kids to have at least one parent they don't detest

- After the Swiss Explosion, Martina and Graciela mourn very badly, Izel rekindled his relationship with his mother but not Graciela

(Izel needs his own post probably lmao)

- Martina tries to move on, but finds she can't.

- listen once a man is willing to cover up war crimes for you, it's a very hard standard to meet

- She rejects the recall initially but to avoid this post from being even longer REASONS, Graciela goes with/gets kidnapped by (it's complicated) Talon, which is how Cole finds out Gabriel is Reaper

- Joins in to get her daughter back, and to redeem herself because she realizes how much destruction she caused even if people deserved it... lowkey she even doesn't fully regret it depending on the person she killed

- Her abilities are she got a CPR glove that can shock people in one hand that can pull Medicated/poison grenades out of a storage and a Pistol in the other and she can inject peeps with medication close quarters.

- She's like 63 currently also (in my Canon, Gabriel got a significant age bump with a bunch of other characters, he is 67 but is technically frozen at age 58)

- blizzard if you read this and wonder why I turned this nameless, possibly faceless character into someone that's committed war crimes, I don't got a fucking clue either

- wildissylupus I'm so sorry for subjecting you to this, like how I will subject my friends to a PowerPoint presentation about my character lore and alternate overwatch timeline on my birthday

[processxe]

Automation and paper elimination in pharmaceuticals with electronic batch records

Batch Records Software

Process XE batch records software workflows are 100% configurable. No coding required.

What is a Batch Record?

A batch record is a record of the history of a manufactured product. It comprises processing instructions to assure its safety, quality, and GMP compliance.

As a result, pharmaceutical businesses choose to use Electronic Batch Record (EBR) in order to streamline production and reduce the potential of mistakes seeping in. This article demonstrates how the system facilitates document generation in the pharmaceutical industry, from bulk to packaging processes.

What is Electronic Batch Records all about?

The pharmaceutical business that wishes to apply innovative solutions in manufacturing is concerned with more than just the digitization of forms. The EBR system is also designed to reduce the time necessary to fill out form fields and eventually lead to automatic form completion by gathering data directly from machines. Data collection directly from equipment such as scales, pH meters, and conductivity meters is frequently required as well. Furthermore, the organization wishes to avoid mistakes and track deviations from the standard that occur during the manufacturing process.

The deployment of the Process XE system results in more than just efficient documentation digitalization. Operators are directed through the manufacturing process, which includes changeovers, quality, logistics, and maintenance. Process XE is being compiled using GMP by the system.

This greatly simplified the process of creating or changing forms. However, this still necessitates the use of authorized individuals; only those with the necessary access may make modifications to the forms. All of this is done to avoid mistakes or inappropriate processing.

What does the Process XE solution offer for Pharma?

Process XE provides an all-inclusive solution that includes machine data collecting, hardware, ERP integration, and infrastructure. This method also allows you to create MBR templates. Clients can develop Master Batch Record (MBR) templates by arranging all actions in the system in the correct sequence and assigning responsibility for each role. Each activity may be customized with several reporting data kinds such as numbers, text, and data retrieved from automation, among others. These results can subsequently be checked against the system's quality limitations.

Fields in forms that have been implemented include whether or not an action has been done. A production value column and information about when a given activity was begun or stopped, as well as a computation of the time spent on it, are also among the modifications. There is also an electronic signature placed on the form and comments or remarks made by the responsible person among the implementations.

What does a paperless procedure in the pharmaceutical sector look like?

The paperless process includes digitally directing the operator through particular portions of production, beginning with the activity display - the production to-do list. It also contains changeover information and documentation for each production phase (picture, text, and video). Using Forms, all paper documentation from production are digitized.

All sheets, tables, and reports are immediately fielded with data from current shifts thanks to Process XE. The system monitors and alerts the operator when the task must be finished. Any modifications or deviations are tracked using an audit trail.

To be released, each batch must go through the Process XE system's approval procedure. This relates to the workflow aspect. The persons who notify certain positions in the organization must sign each step with an electronic signature. If the current step in the workflow is allocated to a certain role, notifications are issued. People with the necessary rights may observe where the batch release process has halted and track KPIs for the time it takes to finish each step.

Digital Records Management with Electronic Batch Records

EBR works because of all of the criteria mentioned above. This provides digital documentation management throughout the manufacturing process. The system ensures that the essential data is entered into the stages. EBR generation yields a PDF file with finished reports and signatures.

What are the benefits of this for the pharmaceutical business?

To begin, the system reduces batch release time by 35% owing to workflow and automatic data collection. Material validation, frequent quality inspections, and step-by-step digital teaching also result in 15% reduced mistakes and waste. It also delivers a 7% boost to OTIF.

The use of EBR also facilitates speedier communication between business divisions, contributes to the removal of paper from the manufacturing process, and allows for round-the-clock monitoring of current batch release statuses.

Process XE provides the solutions your pharmaceutical company need to improve workflow efficiency and environmental friendliness. Please contact a member of the team for more personalized help.

Process XE is web based, flexible and user-friendly software solutions for Business process automation.

This Digital, Smart Manufacturing process automation is principally developed for Pharmaceutical, Life science and Healthcare industries to simplify their manufacturing execution system of various processes such as data capture, batch information exchange, batch production management, data security maintenance, data integrity and report production, ensuring compliance to cGMP requirements.

For more details on MES, Contact our sales team. <Book A Demo>

[darkmaga-returns]

Part 1 ended thus…

“Part 2 will be along tomorrow, and it doesn’t get any better…”

…so sorry for the delay, but I've been travelling for an interview with James Wells, who does documentaries on the vaccine damaged, and then to Parliament for the All Party Parliamentary Group session on Vaccine Damage. More to come on that next week.

In Part 2, we continue with the shocking standards of quality in the SARS-CoV-2 supply chains, primarily down to lack of oversight from the tiny companies supposedly in charge of everything. This time it’s BioNTech’s own facility, hastily purchased from Novartis in the nick of time, or was it?

BioNTech’s COVID-19 Vaccine Manufacturing Facility, Marburg

This article in PHARMACEUTICAL TECHNOLOGY tells us a lot:

BioNTech’s COVID-19 Vaccine Manufacturing Facility, Marburg

It begins:

“BioNTech’s manufacturing site in Marburg, Germany, will be used for the production of its Covid-19 vaccine candidate, BNT162…

…the manufacturing site was acquired by BioNTech from Swiss pharma company Novartis in September 2020 to expand its production capacity to produce a potential vaccine for the treatment of the novel coronavirus…

…BioNTech plans to manufacture up to 250 million BNT162b2 doses in the first half of 2021. The first batch of vaccines produced at the Marburg site is expected to be delivered in April 2021.”

So, here lay the rub. BioNTech purchase the site in September 2020 and it’s producing ‘vaccines’ to be delivered in April 2021.

Lie, lie. lie. Impossible…

…but wait “BioNTech received a manufacturing licence from the Darmstadt Regional Administrative Council for the amended Marburg site.”

The Darmstadt Regional Administrative Council!!! They have no legitimacy to issue a manufacturing licence. Even if they did, the inspection work required to do it would be 12 months or more.

[buzzz-09]

Industrial Batch Ovens: Everything You Need to Know About Their Mechanisms and Operation 🔥

Industrial batch ovens are crucial in modern manufacturing, offering flexible and controlled heating solutions for industries such as aerospace, automotive, food, and pharmaceuticals. Ideal for batch processes like curing, drying, aging, and sterilizing, these ovens provide precise control over temperature, time, and airflow, making them adaptable for diverse production needs.

Ready to optimize your manufacturing process? 🔥 Contact us today to find the perfect industrial batch oven for your needs!

Industrial Batch Ovens: Everything You Need to Know About Their Mechanisms and Operation - Quora