Blog Posts - Cleanrooms



Containment Laboratory Glossary

Bioquell have put together a series of reference guides that contain:A glossary of common terms and acronyms;A selection of useful links to HSE, other regulatory bodiesLinks to appropriate industry bodies.To view the guide, see Bioquell.Posted by Dr.
by Pharmaceutical Microbiology on Dec 17, 2016

ISO 50001 on energy management under revision

Improving energy performance and reducing energy costs is one of the most important tasks that organizations throughout the world have to achieve. ISO 50001 on energy management can help organizations with this exercise. Since its publication five ye...
by Pharmaceutical Microbiology on Aug 24, 2016

GMPs for HVAC in non-sterile pharma

The World Health Organization has issued a draft guidance, titled “Supplementary guidelines on Good Manufacturing Practices for Heating, Ventilation and Air-Conditioning Systems for Non-Sterile Pharmaceutical Dosage Forms.”The scope of the docume...
by Pharmaceutical Microbiology on Jul 14, 2016

Introducing Cleanrooms (book)

Want to know how cleanrooms work? Need to understand the recent ISO 14644 update? Have an interest in how physical design connects with contamination control? Then please see this new publication from Tim Sandle:This book provides an introduction to...
by Pharmaceutical Microbiology on Jul 10, 2016

Revision to cleanroom standard: ISO 14644 Parts 1 and 2

A new article has been published. This article reviews the key changes to International Organization for Standardization (ISO) standards document ISO 14644 Parts 1 and 2, in relation to cleanroom classification. The update requires those responsible...
by Pharmaceutical Microbiology on Jun 29, 2016

Suitability for use of equipment and materials by airborne particle concentration

The following part of the ISO 14644 cleanroom standards is currently going through the drafting process:ISO/DIS 14644-14 Cleanrooms and associated environments- Part 14: Assessment of suitability for use of equipment and materials by airborne particl...
by Pharmaceutical Microbiology on Jun 17, 2016

GMPs for HVAC in non-sterile pharma

The World Health Organization has issued a draft guidance, titled “Supplementary guidelines on Good Manufacturing Practices for Heating, Ventilation and Air-Conditioning Systems for Non-Sterile Pharmaceutical Dosage Forms.”The scope of the docume...
by Pharmaceutical Microbiology on May 18, 2016

New ISO 14644:2016 Part 13 reviewed

ISO 14644-Part 13 ‘Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classifications’ addresses the subject of cleaning cleanroom surfaces to remove particles (surface, in this context, refers to any...
by Pharmaceutical Microbiology on May 16, 2016

Managing Changing Cleanroom Operations

Cleanrooms are designed to insure the area meets the necessary requirements of the clean production process. But what happens when the product changes and a different manufacturing process must be put in place along with new cleanroom requirements? A...
by Pharmaceutical Microbiology on May 14, 2016

Advances with refrigeration systems

Cleanrooms require good temperature and humidity control. In addition to updated electronics, refrigerants used within refrigeration systems have undergone major changes in the past several decades. These changes have largely come about because of up...
by Pharmaceutical Microbiology on May 12, 2016

ISO 14644 Part 15 (cleanrooms) for public comment

The following draft international standard is now available for public comment - ISO 14644-15 Cleanrooms and associated controlled environments “Part 15: Assessment of suitability for use of equipment and materials by airborne chemical and surface...
by Pharmaceutical Microbiology on Apr 10, 2016

ISO Draft International Standard (DIS) 14644-13: available

A new draft cleanroom standard has been produced: ISO Draft International Standard (DIS) 14644-13: Cleaning of surfaces to achieve defined levels of cleanliness in terms of particle and chemical classification.Guidance is provided on the assessment o...
by Pharmaceutical Microbiology on Mar 19, 2016

Lessons Learned in the Cleanroom

Cleanroom components: Install anti-contamination flooring to minimize particulate carry-over, both foot-borne and from cart wheels. Find a qualified third party expert to annually certify the acceptable performance of the air handling systems inside...
by Pharmaceutical Microbiology on Feb 26, 2016

ISO 14644 Part 13 - public comment

Part 13 of the revised international cleanroom standard is available for public comment. The details are:‘Surface’ refers to the interface between two phases. For the purpose of this document, the surface is a solid. “Clean surface” is where...
by Pharmaceutical Microbiology on Feb 22, 2016

Striving for the highest Grade

As a prototype for the future, is it possible to consider an energy efficient filter system that cost-effectively maintains airflow towards a reduced rate of change? Michael Rodd, Chief Sales Officer at M+W Products (www.products.mwgroup.net) looks a...
by Pharmaceutical Microbiology on Feb 21, 2016

Cleanroom Cleaning and Disinfection: Eight Steps for Success

Cleanrooms in healthcare and pharmaceutical facilities must be kept in a state of microbiological control. This is achieved in a number of ways, including the physical operation of Heating, Ventilation, and Air Conditioning (HVAC) systems, control of...
by Pharmaceutical Microbiology on Feb 18, 2016

Contamination Control Under Foot

Control of airborne and surface microorganisms and airborne particles in a cleanroom is achieved through the physical operation of the heating, ventilation, and air conditioning system and cleaning and disinfection techniques.Even with these factors...
by Pharmaceutical Microbiology on Feb 14, 2016

Modern Approaches to Pharma Cleanroom Design

The performance of a cleanroom is defined by a set of complex interactions between the airflow, sources of contamination and heat, position of vents, exhausts, and any objects occupying the space. Consequently, changes to any of these elements will p...
by Pharmaceutical Microbiology on Feb 13, 2016

Testing for High Containment Gloveboxes

High containment gloveboxes (HCG) have been used in the pharmaceutical industry for containment of potent compounds, along with providing specific environmental conditions, for years. These types of glovebox design fit well into the Class III Bio Saf...
by Pharmaceutical Microbiology on Feb 4, 2016

Cleanrooms and clean air

Cleanrooms are highly controlled environments where the air quality is monitored to ensure the extreme standards of cleanliness required for surgical units and for hospital pharmacies.Please find a free paper on this subject below.Cleanrooms and clea...
by Pharmaceutical Microbiology on Dec 20, 2015


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