PrimaPharma expands Analytical Chemistry Laboratory Capabilities

December 2016 – PrimaPharma, Inc. has acquired state of the art Analytical Chemistry equipment including UPLC and HPLC equipment.  “This instrumentation allows PrimaPharma to provide analytical assay service for pharmaceuticals to improve manufacturing process timing with acceptable methods and costs for our customers” says Dr. Nayaz Ahmed, Director of QC and Analytical Services for PrimaPharma, Inc.

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OnDecember 30, 2016, posted in: News by

PrimaPharma acquires capability for aseptic filling of syringes.

October 2016 – PrimaPharma, Inc. announces the acquisition of syringe filling equipment to add to its pharmaceutical manufacturing sterile processing capabilities. The syringe filling equipment will give PrimaPharma the capability to aseptically fill syringes from 0.1mL to 10 mL in lot sizes ranging from 2,000 to 3,000 syringes per 8 hour shift.  The equipment IOQ and media fills to validate the aseptic process have been completed.  PrimaPharma, Inc. is now taking on new pre-filled syringe customers and plans to increase syringe filling capacity over the next 12 months to 14-20,000 units per shift.

 

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OnOctober 1, 2016, posted in: News by

PrimaPharma, Inc. Re-certified to ISO 13485:2003.

May 2016 – PrimaPharma, Inc. recertification inspection by the British Standards Institute was successfully completed and a Certificate of Registration was issued.  British Standards Institute issued Certificate of Registration #FM 59723 expiry date of 2/28/19 to PrimaPharma, Inc at the end of the inspection.  “this re-certification by the British Standards Institute exemplifies the PrimaPharma commitment to quality and compliance which is a core PrimaPharma value” says Mark Livingston, President of PrimaPharma, Inc.

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OnMay 1, 2016, posted in: News by

Sarah Dziabo named associate Director of Quality Assurance.

January 2016 –  PrimaPharma announced today that Sarah E. Dziabo has been appointed associate Director of PrimaPharma Quality Assurance Department.  Sarah has extensive experience in Q.C. & Q.A. working at Medtronic Cardiopulmonary, Alsius, Micro Quality Labs as well as PrimaPharma, Inc.  Her experience includes document control, quality control, quality assurance, analytical chemistry, microbiology, pharmaceutical and medical device manufacturing.

 

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OnJanuary 30, 2016, posted in: News by

PrimaPharma validates High Recovery Vial aseptic process.

January 2016 – PrimaPharma announces that it has successfully validated their aseptic filling process for High Recovery Vials by completion of a rigorous media fill campaign.  High Recovery Vials are a specialty vial with a “V” bottom that allows for a syringe to fully access the contents of the vial with a syringe.  This type of vial is important for “High Value/High Cost” drug products so that nonoe of the drug product is wasted.  PrimaPharma is taking on new clinical trial supplies and commercial customers for this unique drug product packaging option.

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OnJanuary 1, 2016, posted in: News by

PrimaPharm to Sponsor 8th Annual Global Pharma Manufacturing Summit 2013

June 26, 2013 – PrimaPharm will be a sponsor and exhibitor at the 8th Annual Global Pharma Manufacturing Summit 2013 taking place June 27th-28th, 2013 at the Westin Copley Place, Boston.  The Global Pharma Manufacturing Summit is a premier networking opportunity for industry leaders involved in small molecule and biologic pharma manufacturing.  At the event, senior executives and decision-makers from across the pharmaceutical industry will spend two days discussing solutions to the universal challenges organizations are facing.

As a sponsor of the Summit, PrimaPharm will be attending the event as an exhibitor and will have the opportunity to network with representatives of dozens of global pharmaceutical companies potentially in need of CMO services.  Attendees are encouraged to stop by Booth 27 at the event and speak with Mark Livingston and Tony Dziabo about PrimaPharm’s service offerings and capabilities.  Click here for more information about the event.

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OnJune 26, 2013, posted in: News by

PrimaPharm successfully completes latest FDA cGMP inspection

June 18, 2013 – Today PrimaPharm has announced the US Food and Drug Administration (FDA) has completed its most recent inspection of the company’s manufacturing facility.  The entire facility and the quality systems used for the manufacture and release of drug products were subject to a detailed compliance inspection.  The inspection found the facility to be compliant with the principles and guidelines of current Good Manufacturing Practices (cGMPs).

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OnJune 18, 2013, posted in: News by

PrimaPharm Announces Successful ISO 13485:2003 Recertification Audit

March 15, 2013 - PrimaPharm, Inc., a contract manufacturer of drugs and medical devices, announces the successful completion of its ISO 13485:2003 recertification audit for its production facility located in San Diego, California.  PrimaPharm has maintained its ISO 13485:2003 certification with the British Standards Institute since 2000, and the recently completed audit recertifies the company through 2016.

ISO 13485:2003 certifies that a quality management system has been established and maintained that is oriented specifically towards the design, development, production and installation of medical devices and related services.  Certification requires the company to demonstrate its ability to supply medical devices and related services that meet customer expectations and comply with regulatory requirements.  ISO 13485 certification enables PrimaPharm to conduct business internationally in the highly-regulated sectors of the European Union, Canada, and other countries.

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OnMarch 15, 2013, posted in: News by