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
Behind the Headlines, Episode 18
Drug Digest: Patient Preference Drives Solid Dosage Trends
Behind the Headlines, Episode 17
Related Content
Darmstadt, Germany - November 10, 2021: A building at the headquarters of science and technology company Merck KGaA. | Image Credit: © Anne Czichos - stock.adobe.com

MilliporeSigma and Simtra Launch Five-Year Agreement for Drug Substance, Drug Manufacturing Services

Patrick Lavery
June 11th 2025
Article

The agreement has been designed to offer a turnkey service to companies seeking faster time to market.

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.

Abstract vertical illustration of targeting cancer cell made of glowing neon particles. Blue geometric background depicting cancer cell screening and disease treatment medical concept. Digital art | Image Credit: © artacet - stock.adobe.com

Advancements in Biopharma Spur Innovation

Susan Haigney
June 10th 2025
Article

The quickly evolving development of biopharmaceuticals is impacting innovation in the industry overall.

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.

cold storage room with shelves stocked with boxes and containers. Cooling fans and a digital temperature control panel ensure precise climate conditions. refrigeration - storage shelves | Image Credit: © Grispb - stock.adobe.com

Tjoapack Announces Packaging, Cold Chain Expansions in US and Netherlands

Patrick Lavery
June 9th 2025
Article

Most of the company’s new additions, if not already online, will be scheduled for commissioning, validation, or qualification before the fourth quarter of 2025.

Blue and white capsules pill in blister pack arranged with beautiful pattern. Global healthcare concept. Antibiotics drug resistance. Antimicrobial capsule pills. Pharmaceutical industry. | Image Credit: © Artinun - stock.adobe.com

How Smart Technology is Helping Reach Sustainability Goals in Drug Packaging

Patrick Lavery
June 7th 2025
Article

Smart technologies, such as digital and laser printing, incorporated into manufacturing equipment are helping manufacturers align with sustainability goals, according to Sheikh Akbar Ali, general manager and head of Development and Technology for ACG Packaging Materials.