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PDA® Standards Development Call for Volunteers

                         

PDA is very pleased to announce the launch of the Parenteral Drug Association’s fifth standard initiative!  We are seeking volunteer participants to assist in developing, writing, and fine tuning the following proposal:

Standard 05-201x, Consensus Method for Rating 0.1 Mycoplasma Reduction Filters (new standard).

The plan is to base the standard off an existing PDA technical report, TR #75, in order to facilitate standardization of 0.1 µm filter claims for mycoplasma clearance and allow a more effective comparison of mycoplasma removal efficiency by a wide range of filters.

This proposed American National Standard (ANS) was presented by Ms. Martha Folmsbee, Principal Staff Scientist at Pall Corporation.

Those individuals involved in filter manufacturing, filter end-users (both sterilizing-grade and non-sterilizing-grade) and regulators are being sought.

Nominations/Volunteers to serve as a member of the technical team (consensus body) must have some subject matter expertise, and willing to help write/contribute to this standard. Applicants should apply by contacting the PDA Standards Manager at standards@pda.org.  The deadline to submit notification of interest in serving on the consensus body is close of business Friday September 13, 2019.

Latest Discussions

  • Document Name : ASN-0003 Meeting Minutes_8-14-2019 No description provided. Download Latest Revision Submitter : Christine Alston-Roberts Group : BSR/PDA Standard 03-201x, ...

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    RE: PDA TR43 Task Force Kickoff Meeting - Notes for ...

    Posted in: TR43 Revision Team

    Carol, Are you having a conference call now? If so how do I connect? With best regards, Nick DeBello DeBello & Associates LLC Email: nrdebello@gmail.com Phone: 609-364-4282 ------Original Message------ Document ...

  • Posted in: TR43 Revision Team

    Document Name : PDA TR43 Task Force Kickoff Meeting - Notes for distribution 20190726.pdf No description provided. Download Latest Revision Submitter : Ms. Carol Rea Flynn ...