PDA PTC PUPSIT 1

$162

Click Here Concat Us

PDA PTC PUPSIT 1

2020

Most Recent

Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration

PDF FORMAT
Printable
Download

Pre-use/Post-sterilization integrity testing (PUPSIT) has been a widely debated topic for the last several years. To a large extent, the debate has been due to the fact that scientific data were not available to provide additional clarity that could inform appropriate risk-based judgments and commensurate actions. To gain clarity on this and other topics related to sterile filtration, the Parenteral Drug Association (PDA) and BioPhorum formed the Sterile Filtration Quality Risk Management (SFQRM) consortium in late 2017. The consortium goals are to fill existing gaps in scientific data with studies and industry guidance that would provide professionals and license holders with the ability to make informed decisions about quality risk management strategies.

PDA PTC PUPSIT 1
STANDARD INFO:
Standard NamePDA PTC PUPSIT 1
ScopePoints to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration
PublisherPDA - Parenteral Drug Association
LanguagesEnglish
State
Publication Year2020
Most recent VersionMOST RECENT
Whether to be replaced
Addendum
FILE INFO:
File Size1 file , 410 KB
ISBN(s)9781945584176
Number of Pages27
Published02/01/2020
PDA PTC PUPSIT 1
HistoryPublisher Year

Related products

PDA TR 39
2021
Technical Report No. 39 (Revised 2021) Guidance for Temperature-Controlled Medicinal Products – Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation Environment
Most Recent

$162

PDA TR 3
2013
Technical Report No. 3, Revised 2013 (TR 3) Validation of Dry Heat Processes Used for Depyrogenation and Sterilization
Most Recent

$162

PDA TR 54
2012
Technical Report No. 54 (TR 54) Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations
Most Recent

$162

PDA TR 1
2007
Technical Report No. 1, (TR 1) Validation of Moist Heat Sterilization Processes: Cycle Design, Development
Most Recent

$162

individual-home

Over 3,000,000 global standards

Our standards library is extensive, with over 2 million documents, ensuring we meet the needs of various industries. Whether it’s ASME, DIN, ASTM or ISO and other internationally recognized standards, we offer complete documents and the latest versions to help customers adhere to industry regulations in their projects. Whether your needs are technical standards, regulatory requirements, or design guidelines, our standards library provides comprehensive support.

24 online customer service

Our team includes up to 50 engineers from fields such as healthcare, electronics, and construction, who can answer your technical questions and ensure you find the correct and accurate standard documents. We are dedicated to helping you find the best solution that meets your needs.

The reviews
What People Are Saying

Thanks to the StandardsClub customer service team for helping me find the ASME BPVC-2023 SET I was looking for in a high-quality PDF version. Their assistance was excellent, and the document quality exceeded my expectations!

This standard document is very detailed, covering all relevant technical points, and provides comprehensive guidance for my project. The ANSI/NEMA Z535 SET was exactly what I needed, and I am very satisfied with the quality!

The purchasing process was straightforward, the price was very competitive, and the download was quick. The Tissue Engineering Standards Addressing Product Quality and Characterization Package was of excellent quality and provided all the information I needed. Definitely a great value for the price!

HAVE A QUESTIONS ABOUT?
Everything is here to help you.

“Got questions? Our professional customer service is ready to assist you anytime. Whether it’s finding documents, getting discounts, or navigating the purchase process, let us help you get the standards you need!”

Sign Up Our Newsletter

Don’t miss out! Subscribe now to get exclusive offers and industry insights!

We care about your data in ou privacy policy.

Shopping Cart
Scroll to Top