PDA Survey: Electronic

PDA Research: 2017 PDA PUPSIT Survey (single user digital version)

In March of 2017, PDA conducted a benchmarking survey to better understand the current situation regarding sterile filtration and the implementation of Pre-Use Post Sterilization Integrity Test, or PUPSIT, among large pharmaceutical companies. Due to increased enforcement of section 113 of Annex 1 by European regulatory agencies, manufacturers of sterile medical products are finding they must modify their manufacturing processes to incorporate the PUPSIT and/or are not able to justify its exclusion on risk-based principles. The survey was open to PDA members with subject-matter expertise in PUPSIT and who hold the manager level position in biologic process development, manufacturing, validation, and/or quality. Readers are encouraged to draw his/her own conclusions from the presented summarized data and responses.

*PDA members must log in above to see the correct price for your membership type.

PDA Standard, Young Professionals & Government members can access this document for free until February 18, 2018.

PDA Members — How to download PDA Research: 2017 PDA PUPSIT Survey
  • Please log in with your PDA ID number and password. The login button is located at the top right corner of the page.
  • Once you have logged in please click the "Claim your free members-only download" button.
  • Click on the product you would like to download. You will be asked to Open or Save the document; PDA recommends that you immediately save the document to your computer. Each time you open the document you will be prompted to provide your PDA password. The document password is the same as your PDA password at the time of your download and cannot be changed.
  • Your free version of PDA Research: 2017 PDA PUPSIT Survey is electronic only and will not be shipped in hard copy.
  • Please feel free to contact the Customer Service Department with any questions at membership@pda.org

Available to download
Format: PDF (1 file 2.53 MB)

Click here to view the digital downloading instruction and Terms of Usage

Table of Contents:

Questions and Answers

Date of Publication: January 2018
ISBN Number: 9781945584015
Format: PDF
Number of Pages: 24