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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 Monday October14, 2019.

Latest Discussions

  • Dear Team, In light of our focus on the rFC assay for endotoxin testing, I am sending along a link to and PDF version of the proposed update of USP <85> BET which includes language for the use of rFC for the BET. https://online.usppf.com/usppf/document/GUID-F9D9BFA5-099F-452C-9711-47674B37C1CC_20101_en-US ...

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    RE: Scope review for Project

    Here are my comments. Duncan ------Original Message------ Greetings ASN-0004 Members! Thank you all again for participating in yesterday's introduction call. Please review and fine tune the scope information from the proposed project  listed ...

  • Greetings ASN-0004 Members! Thank you all again for participating in yesterday's introduction call. Please review and fine tune the scope information from the proposed project  listed below, as well as the appendices of the technical report for your ...