Non-Sterile is Non-Sterile: A Reality Check on Microbial Control Expectations

Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology-05-15-2016
Volume 2016 eBook
Issue 2
Pages: s31-s35

This article discusses the issue and offers food for thought and suggestions for more science-driven approaches.

USP requirements for the absence of “objectionable organisms” are well intended, but may often result in the need for subjective, and unrealistic, determinations. This article discusses the issue and offers food for thought and suggestions for more science-driven approaches.

Download

Pharmaceutical Technology’s 2016 Bioprocessing and Sterile Manufacturing eBook

.

 

 

 

 

Articles in this issue
Measuring-and-Removing-.jpg
Measuring and Removing Genotoxic Impurities
Sartorius-Shipping.jpg
Qualification and Validation of Single-Use Shipping Systems
The-Evolution-of-Planning.jpg
The Evolution of Planning, Design, and Engineering—Flexibility Takes Center Stage
Revised-Iso-Cleanroom.jpg
Revised ISO Cleanroom Standards Improve Air Cleanliness Classification
Lessons-Learned-Accelerate-Vaccine.jpg
Lessons Learned Accelerate Vaccine Development
Protecting-the-Product-and-the-Patient.jpg
Protecting the Product and the Patient
Deconstructing-the-Regulatory.jpg
Deconstructing the Regulatory Spiral
Non-Sterile-is-Non-Sterile.jpg
Non-Sterile is Non-Sterile: A Reality Check on Microbial Control Expectations
Recent Videos
Drug Digest: Strategic Partnerships
Michelle Bridenbaker from Unbiased Science discusses her thoughts on the key industry from 2024 and those she anticipates will impact the industry in 2025 and beyond.
Roger Viney from ICE Pharma discusses the quality and compliance issues surrounding the use of animal-derived ingredients in the bio/pharma industry.
Tore Bergsteiner from MAIN5 discusses the most pertinent and impactful bio/pharma industry trends from 2024.
Related Content
Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Beckman Coulter Life Sciences Launches Modular Spectral Flow Cytometry Module, First of Its Kind in Industry

Feliza Mirasol
March 28th 2025
Article

The CytoFLEX mosaic Spectral Detection Module offers up to 88 channels for detection.

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas
June 25th 2024
Podcast

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - © Cagkan - stock.adobe.com

Sherwin-Williams to Showcase Next-Gen Coatings for Pharma Cleanrooms at INTERPHEX 2025

Feliza Mirasol
March 28th 2025
Article

Sherwin-Williams’ advanced coating systems are designed to ensure safety, sterility, and efficiency in pharma manufacturing environments.

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas
May 28th 2024
Podcast

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

TOP NEWS on grunge world map | Image Credit: © Sean K - stock.adobe.com

BIO Survey: Tariffs May Reduce Access, Delay Innovation, Create Red Tape

Patrick Lavery
March 27th 2025
Article

The Biotechnology Innovation Organization’s new membership survey said that 90% of US biotech companies rely on imported components for at least half of their FDA-approved products.

Science laboratory test tubes, laboratory equipment | Image Credit: © BillionPhotos.com - © BillionPhotos.com - stock.adobe.com

Novartis’ Steady Investments in Slovenia Result in New Viral Vector Manufacturing Facility and a Growing Work Force

Feliza Mirasol
March 27th 2025
Article

With a completed €40 million (US$43 million) investment in Slovenia, Novartis has opened its first specialized viral vector production facility in Europe, following earlier significant investments in R&D that has led to the growth of Slovenia’s workforce.