#Laboratory Incubator Manufacturer in Ahmedabad

[navsarjan]

EU GMP Consulting and Regulatory Compliance Service

As leading EU GMP Consultant we offer a broad range of services, from EU GMP compliance, qualification & validation, TGA regulatory, engineering and architectural consulting services to the following industries medicinal cannabis, pharmaceutical, blood & tissue, pesticides, veterinary and medical device manufacturers, as well as related hospital and pharmacy operations. See industries we serve.

PharmOut is a professional EU GMP Consultant specializing in supporting the medicinal cannabis cultivation industry and new generation medicines pharmaceutical production industry, cosmetics, medical devices, veterinary, Pharmaceutical Consultants in Ahmedabad with offices in Australia, Hong Kong, New Zealand, South Africa, the United Kingdom and United States. As experts in FDA, PIC/S and EU GMP consulting, we can help you.

What PharmOut Offers

PharmOut holds ISO 9001:2015 certifications from LQRA and our Quality Management System is certified to the ISO 9001:2015 standard for the provision of architectural design, engineering and consultancy services.

PharmOut carefully selected Growers, Engineers, Architects and Consultants all have many years of experience spanning the wide reaches of industry from pharmaceuticals and biologic to pharmacy, veterinary and medical device industries and since 2016, Medicinal Cannabis Consultants and growing experts.

We have seen and understand most the problems that can occur from the initial facility design all the way to scale up development and manufacturing and we have experience that can help to prevent costly and time consuming mistakes as well as address any problems you might have.

As a leading pharmaceutical consulting company, our aim to give you a competitive advantage and our expert EU GMP Consultant, trainers, pharmaceutical engineers and architects are focused on providing practical, cost effective EU GMP compliant solutions, all of which have a focus on improving your bottom line across the entire life cycle of your products.

PharmOut shares information generously in the form of whitepapers, blogs, free tools and past presentations.

QA, GACP and EU GMP Consultant Expertise

Medicinal Cannabis – our Medicinal Cannabis Consultants can offer practical knowledge and experience on implementing or enhancing your Pharmaceutical Quality Systems (PQS) to meet GACP and GMP code requirements from various agencies like the USFDA, EU and PIC/S.

Pharmaceuticals – our pharmaceutical consultants can offer practical knowledge and experience on implementing or enhancing your Pharmaceutical Quality Systems (PQS) to meet EU GMP code requirements and those based on ICH Q10 / ISO 9001:2015 for Pharmaceuticals.

EU GMP Audits – we can help with GCP, GLP and GMP gap audits / assessments / remediation plans to help you prepare for regulatory audits and inspections from agencies such as the TGA/MHRA/US FDA.

Medical Devices / IVDs – we are experienced in ISO 13485 and have implemented a number of ISO 13485:2003 and ISO13485:2016 Quality Management Systems for medical device manufacturers as well as implementation to meet US FDA 21 CFR Part 820 requirements in the past few years.

Blood and Tissue – we can advise on blood and tissue GMPs – including the country-specific GMPs like those issued by the TGA or Annex 2 from the EU and PIC/S codes of GMP.

Pesticide and Veterinary Drug – we can assist with GMP compliance to the US FDA, EU and the APVMA GMP codes.

Qualification and Validation of Facilities, Utilities, Systems, Equipment and Computerized Systems

Process validation – we offer Pharmaceutical and Medical Device process validation that will comply with PIC/S, EU EMA and US FDA regulations.

Equipment validation – we can validate the equipment you have according to pharmaceutical and international regulatory standards in accordance with current Good Manufacturing Practice.

Cleaning validation  – we can validate cleaning protocols in place for your pharmaceutical and medical device manufacturing facilities.

Computer systems validation – we offer computer systems validation to US FDA 21 CFR Part 11 and TGA, EU and PIC/S PE 009 Annex 11 regulations.

Temperature mapping  – we have the expertise and equipment on hand to perform temperature mapping of your warehouses, cold rooms and other temperature controlled spaces.

Architectural and Engineering Consulting Services

We can help you design, build and operate manufacturing facilities that will fully comply with international Good Manufacturing Practice (GMP) regulations as issued by agencies such as the FDA, MHRA, CFDA and other PIC/S member agencies.

Our growers, architects and engineers are experts in designing world class health science facilities such as hospitals and aged care units as well as GLP laboratories and GMP-regulated manufacturing sites and cleanrooms. They will ensure that work done adheres to the correct standards and help to avoid costly mistakes.

We also offer a facility design review service and can give an informed independent review of your facility plans to ensure regulatory compliance and efficient workflows within a facility or a medicinal cannabis grow house.

Regulatory Affairs – Medical Device / Drug Registration

We can provide advice and answer your questions on the Australian TGA’s medical device and drug registration process as well as prepare dossiers to support drug or device registration with the TGA and conduct mock ISO 13485 audits.

On-site Contracting Services

If you need human resources for a project, we have Pharmaceutical Engineers, GMP Consultants, Validation Consultants, Regulatory Affairs Consultants and Technical Document Writers available at short notice to send to your site at competitive rates.

On-site and Public GMP Training

We offer a wide range of online GMP training courses, these can be purchased and performed as individual courses or bundled courses focused by industry, region and regulatory agency, i.e. specific to TGA, MedSafe, PIC/S, US FDA or EU.

Our architects, engineers, scientists and EU GMP Consultant regularly offer a wide range of public GMP training courses in Adelaide, Auckland, Brisbane, Hong Kong, Melbourne, Perth and Sydney. We also frequently fly to any location in the world and deliver GMP training onsite and Medicinal Cannabis Training.

Medicinal Cannabis Consultants

PharmOut has an enviable track record of successfully helping numerous medicinal cannabis compliance applications around the world with over 100 facility designs to date. Within the Australia / New Zealand region, we are the leading Medicinal Cannabis Consultants offering turn key designs for indoor, greenhouse and outdoor facilities. To our knowledge PharmOut is the only company in the world that can offer a full range of services from licensing, cultivation, production, extraction to final dosage forms with Architects, Compliance, Engineers, Growers and Validation experts under one roof. We like to think of it as hardware (facility design and engineering) and software (paper systems), after all GMP is often said to mean “Get More Paper”.

[batbioreactor]

rotary shaker manufacrurer in india

Rotary Shaker

Features

·       Powered by continuous duty, variable speed self cooled Motor with adjustable Orbital speed from 0 to 144 RPM. 

·       Top Sheet Made Of SS 304 Material For Flask Mounting

·       Base Structure Made Of Mild Steel Material Painted With Red Oxide

·       Rotate With Eccentric Mechanism

·       Variable Frequency Drive For Speed Controlling

·       Digital Display For RPM Indication

·       Digital Timer For Schedule Shaking Time Setting

·       Outer Cover Made Of Powder Coated Mild Steel Material

·       Angle Iron Structure Painted With Red Oxide

·       Fixed Eccentricity Stroke 15.5mm

Uma Pharmatech Machinery  engaged in designing, manufacturing, research, training, troubleshooting in Fermentation and Bioreactor equipment and plant.

Uma Pharmatech Machinery focused towards customer satisfaction, We adopted a customer-oriented approach and Serving clients all across globe, We developed a complete understanding clients requirements and offer customized services such as Fermenter / Bioreactor Plant for various application for clients as this helps in delighting our customers and building close relationships with them.

  We are Looking Buyers for industrial fermenter  from Middle east countries like Egypt, Iraq, Saudi Arabia, Yemen, Syria, UAE, Dubai, Israel, Jordan, Palestine, Lebanon, Oman, Kuwait, Qatar, Bahrain, Iran and African Countries like South Africa, Nigeria, Egypt, Algeria, Angola, Morocco, Sudan, Tunisia, Ghana, Libya, Kenya, Ethiopia, Cameroon, Ivory Coast, Tanzania, Equatorial Guinea, Zambia, Botswana, Uganda, Gabon, Democratic Republic of the Congo, Republic of the Congo, Senegal, Mozambique, Namibia, Mauritius, Mali, Madagascar, Burkina Faso, Chad, Zimbabwe, Benin, Rwanda, Nigeria, Malawi, Guinea, Mauritania, Swaziland, Togo, Eritrea, Lesotho, Burundi, Sierra Leone, Central African Republic, and all over India

Regards

UMA PHARMATECH MACHINERY(CEO)Mr. Ankur Patel

(

+91-9726923885

)

umapharmatechmachinerys@gmail.com

Ankur patel

| Managing Director | Uma Pharmatech Machinery |

Address:  14, Narayan Chamber, Jogeshwari Estate, Sureliya Road, Pin-380026 , ahmedabad | Gujarat | India |

Products & Services: Bioreactor I Fermentors I Laboratory fermentors I fermentors For Bio fertilizer  I Laboratory Flask Shaker I Incubator Shaker I Horizontal and Vertical Autoclaves I Medical Autoclaves I Electric Steam Boiler I Processing and Storage ss Vessel and Tank I Tc Fittings For Dairy Pharma I PP and PTFE  Cartridge and Filter Housing I Pharma components & parts I Turnkey projects I Ribbon Blender I Double Cone Blender I V Blender  I Paste Kettle

____________________________________ Made in India ______________________________

Think before print..One earth...One chance....Go green!

The Intelligent& Excellent bio engineering

[bavishifertility]

IVF at Bavishi Fertility Institute, Ahmedabad

Anything which occurs outside the body is called in vitro and when fertilization of egg with sperm occurs outside the body it is called “IN VITRO FERTILIZATION”. The first In Vitro fertilization was done in the test tube and that is why it is popularly known as Test tube Baby.

The process of fertilization which normally in fallopian tube of the woman and the fertilized egg than moves into the uterus of the woman. It an implants there in to the uterus and developed into the baby. When for some reason this process of fertilization cannot take place naturally or sperm and egg cannot be transported naturally to the tube or from the tube to the uterus or either is egg having some problem or the sperm.

Some problem in fertilization during test tube baby process we need to asses the fertilization to help fertilization we take out of the egg from the wife of egg from the woman’s ovary and in control lab and environment we fertilized egg with the help of sperm of her male partner. After fertilization the fertilized egg are cultured into the control laboratory environment to form pre-embryos and this pre-embryos are then transferred back into the uterus of the woman. If they implant and grow become the pregnancy, and hence test tube baby is most convenient process.

IVF – Step By Step

Preliminary testing

This includes first consultation, blood tests culture if necessary, hysteroscopy, D21 visit i.e. mock transfer trial, semen freezing and serum progesterone.

First consultation

We will complete a history and physical examination of both partners.

Transvaginal sonography of female partner and semen examination of male partner and culture of it, if necessary. It is helpful to bring of your old medical reports, if available.

First consultation

We will complete a history and physical examination of both partners.

Transvaginal sonography of female partner and semen examination of male partner and culture of it, if necessary. It is helpful to bring of your old medical reports, if available.

Base line blood investigation

This includes D3 FSH, LH, PRL, TSH, Major pre operative profile and other special blood investigations if necessary This will help us to choose best stimulation (Medication) protocol to complete your IVF cycles.

Hysteroscopy

If you have previously had a hysteroscopy please bring their reports. This test must be scheduled to be completed on days 5-11 of the menstrual cycle. Menstruation must be absent for this test to be done.

D21 visit

Semen freezing

Mock transfer trial

Serum progesterone

TVS

Semen freezing: It is necessary to freeze a semen specimen before your IVF cycle starts. This sample is used only as an emergency back up for the day of retrieval. We prefer to inseminate the eggs with fresh semen if possible. We will discard the sample after completion of cycle except if you choose to have another IVF cycle.

Transvaginal sonography will tell us thickness of endometrium on D21.

Serum progesterone level estimation.

Mock transfer trial: Embryo transfer is very important procedure and it is usually done without anesthesia so, on day 21 we will do mock embryo transfer to anticipate any difficulty and solution far it before actual transfer. It is painless procedure.

Development of oocytes (Eggs)

It is necessary to stimulate the ovary to produce multiple follicle (the sac that contains the egg), in order to improve your chances of a successful outcome from an IVF cycle. After the consult with the doctor, you will receive prescription for a specific type of medication stimulation protocol. There are many different medication protocols that the doctor may prescribe for you. This decision is based on factors such as your age, infertility history, a past response to these medications, and a base line FSH level. The fertility medications that are necessary to stimulate the ovary are unfortunately all injectable medications. Doctor and nurse will explain you the dosage and method of administration.

Fertility Medication

If we have more than one egg we have better chance of pregnancy of in IVF cycle. To get more eggs we stimulate the ovaries with stimulation drugs called gonadotrophins. Gonadotrophins can be manufactured from urine or by recombinant DNA technology. Appropriate type of gonadotrophins and dose of administration are selected for individual patients. Available gonadotrophins include HMG, FSH and recombinant FSH manufactured by different pharmaceuticals.

Side Effect Of Fertility Medication

Over stimulation of the ovary, It can occur to varying degrees: mild, moderate or severe.

Multiple births:

The risk of conceiving a multiple pregnancy during and IVF cycle is dependent upon your age, response to the medications, the quality of the embryos, the number of embryos replaced into the uterus and other unforeseen factors are considered when judging your specific risk of multiple births.

Common complaints:

Pain at the injection site, headaches and fatigue.

Special note:You may have read reports that fertility drugs increase the risk of ovarian cancer. To date there are no conclusive studies that identify an association between taking fertility drugs and ovarian cancer.

GnRH analog (Lupride)

This medication is administered by subcutaneous injection. It is given to prevent premature release of the oocytes (eggs). Side effects may include: localized skin reaction, allergic reaction, headaches, hot flashes and mood swings. If your scheduled menstruation is late while on Lupron, you should have a pregnancy test.

HCG (Human Chorionic Gonadotropin)

You will be given instruction for the exact time of this injection. It is generally taken 34-36 hours prior to the egg retrieval. This medication should be injected into the muscle. This medication completes the maturation of the egg.

Progesterone

You will begin talking this naturally occurring hormone on the next to egg retrieval. This medication, assist the embryo to attach to the uterus.

The side effects that have been reported include: breast tenderness, headache, nausea, fluid retention, fatigue, mood swings, depression, pain at the site of injection (in the case of injectable progesterone).

Vaginal itching and irritation (in the case of vaginal form). If you have a history of blood clots or thrombophlebitis you should alert the medical staff.

Sperm Collection And Insemination

While the egg retrieval is underway, you will be notified by the andrology/embryology staff that a sperm sample is needed. The specimen will be processed in our laboratory and prepared for egg insemination.

Please discuss with the embryology staff if any question or concern you may have prior to the day of egg retrieval. Frozen specimen collected will be used only in case of emergency (illness, inability to procedure a specimen etc.)

Oocyte (Egg) Retrieval  

The egg collection process (retrieval) is usually accomplished using the Ultrasound-guided trans vaginal method. Other methods of retrieving oocyte that are rarely utilized in our practice but are sometimes necessary, include Laparoscopy or a Trans-Abdominal approach.

This ultrasound-guided trans vaginal method of egg retrieval allows this procedure to be done in an out patient setting. A vaginal ultrasound allows for visualization of both ovaries.

A needle is inserted through the vaginal wall in the ovary. Each follicle is punctured individually and the fluid containing the egg is examined by the embryologist under the microscope until the egg is found. The duration of this procedure is usually less than 45 minutes.

This procedure is done under general anesthesia.

Incubation And Fertilization Of Oocytes (Eggs)

The eggs and sperm will be placed together in a special culture fluid and kept in incubators in our laboratory. This procedure is called insemination.

Formation And Cleavage Of Embryos

The eggs will be examined 16-20 hours after insemination for signs of fertilization. If fertilization occurs, the fertilized eggs are now described as pre-embryos or zygotes. When they divide to at least 2 cells they are called embryos.

The laboratory environment is conducive for fertilization to occur, however, it cannot be guaranteed that fertilization will occur. Typically, 60% of the eggs retrieved will be fertilized. This percentage may be higher or lower depending on each couple.

Embryo Transfer

Embry transfer (ET) usually occurs forty eight to seventy two hours post retrieval. The time of transfer will be designated by the IVF staff. The embryo(s) that is (are) assessed to be developing normally will be considered for transfer. Although a recommendation (3-5 embryos) will be made regarding the number to transfer, the final decision resides with the couple and the doctor.

Transferring multiple embryos may result in the growth of more than one foetus. If you have extra embryos after the transfer, they will be cryopreserved if they have demonstrated appropriate development.  

The method used for transferring embryos is similar to that of the mock transfer. ET is performed by inserting a small catheter through the cervical opening into the uterine cavity. The embryo transfer is usually a painless procedure. There is a recommended rest period after the transfer. You will be given specific instruction prior to the transfer regarding your medications, future testing dates and activity restrictions.

Within 13 days post-transfer, hormonal levels and a pregnancy test will be done. If a pregnancy has occurred, further blood testing blood work and ultrasound will be required to assess normal progression.

Cropreservation (Freezing) Programme

The purpose of embryo freezing programme is to give a couple participating in the IVF programme the best chance to achieve a pregnancy with a maximum of safety. At the end of an IVF cycle there are often multiple embryos available for transfer. It has been found that transferring more than four embryos caries a significant risk of multiple pregnancies, while it does not increase the singleton pregnancy rate proportionately. The advantage of cryopreservation is that there may be an increased chance of pregnancy without the necessity of multiple stimulation cycles and oocyte retrievals. 

The frozen embryo transfer takes place in an identical manner to a fresh embryo transfer.

Embryo selected for cryopreservation will be frozen up to three days after the egg retrieval. The embryos will be placed in a cryopreserved media and frozen in a step-wise manner. At the end of the cryopreservation procedure the embryos will be stored frozen in tanks filled with liquid nitrogen. Brought back to normal life. There is no guarantee of the survival of human cryopreserved thawed embryos. If they have not survived (as seen at the time of thawing), they will not be transferred. We consider couples whose eggs and sperm become an embryo to be the owners and persons who control their embryos. However, there is a time limit on this ownership and control. 

The method used for transferring embryos is similar to that of the mock transfer. ET is performed by inserting a small catheter through the cervical opening into the uterine cavity. The embryo transfer is usually a painless procedure. There is a recommended rest period after the transfer. You will be given specific instruction prior to the transfer regarding your medications, future testing dates and activity restrictions.

Within 13 days post-transfer, hormonal levels and a pregnancy test will be done. If a pregnancy has occurred, further blood testing blood work and ultrasound will be required to assess normal progression. 

For more such blogs, please visit- http://www.ivfclinic.com/blog/

[navsarjan]

Pharma Project Consultants Service Provider from Ahmedabad

The Pharmaceutical Consultants in Ahmedabad is governed by regulations which are different in different countries. A regulatory pharmaceutical FDA audit is an imperative and apparently feared event. The fortune of a Pharmaceutical Consultants in Ahmedabad license depends on its final result. According to the diverse market's demand, many regulatory agencies periodically have to adhere the standard and regulations of the company. The pre-determined regulatory standards are a part of series of activities and procedures reviewed by FDA audit. In general, FDA audit in Pharmaceutical Consultants in Ahmedabad is distinctly positioned to determine the existing capability of manufacturing processes to affirm safety and standardization. The whole process is outlines by an audit report and provides an abstract of the audit findings.

 It is desirable in every progressive Pharmaceutical Consultants in Ahmedabad that the audited report be induced to grow a positive and professional attitude. In this process of audit, the skills of each participant should be upgraded and enhanced. The goal for highest possible standards cannot be considered as being too ambitious. Constant and fierce competition demands the "Right First Time" approach. Safety and promise quality can be ensured only by accurate assessment and thus help to evolve best practices. FDA audit is acknowledged as a necessary evil by innumerable professional involved in Pharmaceutical Consultants in Ahmedabad. It has to be faced with preparation and one has to adapt accordingly.

It has been highlighted that focused training in this field is a neglected area. Many individuals have been self-trained in this procedure only because they have been subjected to several audits in the past. The success rate is dependent on the experience they have gained gradually.