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
Jens Schmidt, associate director MSAT at Lonza
Christian Dunne, director of Global Corporate Business Development at ChargePoint Technology
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

EMA Prepared for Health Technology Assessment Regulation Implementation

Susan Haigney
January 10th 2025
Article

The HTAR, which aims to increase access to new medicines, becomes effective Jan. 12, 2025.

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.

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

J&J Gets FDA Fast Track Designation for Alzheimer’s mAb, Posdinemab

Feliza Mirasol
January 9th 2025
Article

Posdinemab is the second tau-directed investigational therapy by J&J that has received fast track designation from FDA this year for Alzheimer’s disease.

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.

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 Releases Draft Guidance on Sampling and Testing of In-Process Materials and Drug Products

Susan Haigney
January 3rd 2025
Article

The draft guidance document provides recommendations for complying with 21 CFR 211.110.

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 Announces Reopening of Comment Period Regarding HCP Immunogenicity Risk from Follow-on Recombinant Peptides

Feliza Mirasol
January 3rd 2025
Article

The comment period for the Federal Register Notice, “Evaluating the Immunogenicity Risk of Host Cell Proteins in Follow-on Recombinant Peptide Products: Establishment of a Public Docket: Request for Information and Comments”, has been reopened by FDA until March 3, 2025.