Importance of Background Microbial Levels in the Manufacture and Testing of Sterile Products

News
Article
Pharmaceutical TechnologyPharmaceutical Technology-04-02-2005
Volume 29
Issue 4

The sterility testing of samples from an aseptic process may be considered an entirely separate aseptic process that is subject to the same types of adventitious contamination as the aseptic process itself.

External Link - article-155377.pdf

Articles in this issue
Analytical Methods Validation In-Process Control Methods for the Manufacture of Active Pharmaceutical Ingredients
April 2005
Management Controls for GMP Compliance
The Sector Chart: A New Engineering Graph for Pharmaceutical Processes
Validation of Alternative Microbiology Methods for Product Testing Quantitative and Qualitative Assays
PAT and Process Understanding: A Call to Arms
Cold Chain Concerns
Evolutions in Direct Compression
X-ray Microtomography of Solid Dosage Forms
Orient Express
Importance of Background Microbial Levels in the Manufacture and Testing of Sterile Products
Using Visible Residue Limits for Introducing New Compounds into a Pharmaceutical Research Facility
Comparative Evaluation of Three Active Air Samplers for the Monitoring of Airborne Microorganisms
Famine in Field Inspection
Establishing Target Fills for Semisolid and Liquid Dosage Forms
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.
Tore Bergsteiner from MAIN5 details his predictions for how the mega trends will shape the bio/pharma industry in 2025 and beyond.
Tore Bergsteiner from MAIN5 discusses the most pertinent and impactful bio/pharma industry trends from 2024.
Related Content
TOP NEWS on grunge world map | Image Credit: © Sean K - © Sean K - stock.adobe.com

FDA CBER Director Peter Marks Resigns

Susan Haigney
March 31st 2025
Article

Marks called out an ‘assault’ on truth and science in his resignation letter, which has sent the bio/pharmaceutical industry reeling.

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: A Closer Look at mRNA in Oncology and Vaccines

Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines

Feliza Mirasol
April 30th 2024
Podcast

In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.

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.