Revised ISO Cleanroom Standards Improve Air Cleanliness Classification

Publication
Article
Pharmaceutical TechnologyPharmaceutical Technology-05-15-2016
Volume 2016 eBook
Issue 2
Pages: s18-s22

Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.

Revised versions of ISO 14644 Parts 1 and 2 introduce changes to sampling procedures and monitoring plans for cleanrooms and clean zones.

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
Related Content
Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

European Pharmacopoeia Goes Digital

Susan Haigney
June 25th 2025
Article

The 12th edition of the European Pharmacopoeia will be an all-digital, redesigned, user-friendly issue.

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.

Pharmacist weighing chemical | Image Credit: © Kzenon - stock.adobe.com

Pharmaceutical Compounding Calculations, Part Two–Bulk Drugs

Paul L. Pluta;Nishant B. Thakar;Varanya Chaiyaperm
June 23rd 2025
Article

Bulk drug calculations for different types of active moieties and drugs require different calculations and labeling.

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.

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

BASF Opens GMP Manufacturing Facility in Michigan

Susan Haigney
June 19th 2025
Article

The new facility offers cleanroom packaging and high-sensitivity analytical testing.

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

FDA Voucher Program Provides Shorter Drug Application Review Time

Susan Haigney
June 18th 2025
Article

The Commissioner’s National Priority Voucher can be used by drug developers to participate in a novel priority program for shortened drug approval review time.