New ISPE Guide for Controlled Temperature Chambers
ISPE announced the release of the ISPE Good Practice Guide: Controlled Temperature Chambers – Commissioning and Qualification, Mapping and Monitoring (Second Edition).
Cleanroom HVAC Design
Standards and Classifications, Particle/Contamination Sources and Control, Design Considerations, Flow Patterns and Floor Arrangements, Airflow Quantity and Demand Flow Control, Pressurization and Airlocks, in addition to Typical HVAC Air-Handling Systems and Selection.
Classification of air cleanliness by particle concentration
ISO 14644-1:2015 Cleanrooms and associated controlled environments Part 1: Classification of air cleanliness by particle concentration ISO 14644-1:2015 specifies the classification of air cleanliness in terms of concentration of airborne particles in cleanrooms and...
ISPE International Society for Pharmaceutical Engineering
ISPE International Society for Pharmaceutical Engineers ISPE delivers technical and operational solutions to support its Members across the global pharmaceutical and biopharmaceutical industry. ISPE positions itself as a center of excellence in the pharmaceutical...
USP 800 Guidelines
800 Hazardous Drugs—Handling in Healthcare Settings Based on the public comments received for the proposed 800 in PF 40(3), the USP Compounding Expert Committee has developed a revised chapter. The USP 800 chapter has been created to identify the requirements for: The...
USP 797 Cleanroom Performance
USP General Chapter <797> provides standards for compounding sterile preparations to promote patient safety and prevent harm. These standards help ensure patients receive quality preparations that are free from contaminants and are consistent in intended identity, strength and potency.
Clean Room Sticky Mats
What type of sticky mat is right for my cleanroom? Clean Room Sticky Mats that are machine washable as well as peel up sticky mats come in a variety of types, sizes and prices. Selecting the appropriate type of mat for your modular cleanroom environment will depend on...
ABSA – American Biological Safety Association
ABSA – American Biological Safety Association ABSA – American Biological Safety Association ABSA International (ABSA) was founded in 1984 to promote biosafety as a scientific discipline and serve the growing needs of biosafety professionals throughout the...
Clean Room Classification & Cost Implications
Clean room Classification and clean room size greatly affects the cost of a clean room, both from a planning and implementation cost perspective, as well as an operational cost perspective. Many customers will come forth with the idea that they will build a larger clean room than necessary – just in case they need the extra space. This often times results in increased operational costs and unforeseen expenses.
Clean Room Class Selection
Is there a problem with building a higher clean room class than needed? Every time you go up a clean room class or down a class in a clean room it has varying levels of cost, space and design requirements. For instance if you go up one class clean room classification...