Cleanroom Industry News
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...
GMP Guidelines
Australian GMP Guidelines Questions & answers on the code of good manufacturing practice for medicinal products Technical Guidance on the Interpretation of Manufacturing Standards for Supplier Qualification Canadian GMP Guidelines Annex 2 to the Current Edition of...
Pack Expo Las Vegas 2017
Only Healthcare Packaging EXPO gives your company exposure to the mega-audience of PACK EXPO Las Vegas—30,000 buyers from virtually every vertical market. The world’s top CPGs send engineers and managers to PACK EXPO in search of innovative approaches to packaging and production. It’s a great opportunity to offer creative applications for your product.
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...
Lab Safety Information
Laboratory Safety Laboratories are designed to maintain the health and well-being of occupants. Potentially hazardous substances used in different laboratories include chemicals, radioactive materials and infectious biological agents. These materials can be...
ISO Cleanroom Standards Committee
ISO cleanroom standards offer international consistency and have been developed by a technical committee of controlled environment subject matter experts.
ISO Cleanroom Classifications
Originally the U.S. General Service Administrations's standards known as FS209E were used as the global standard. Since then, global classifications and standards have been created and adopted. The ISO cleanroom standards offer international consistency and have been...
Cleanroom Air Filtration a Necessity
Air filtration for cleanrooms is a necessity to business continuity in an aseptic environment. Hepa and Ulpa clean room air filters are used to decrease the amount of particulate in the air. Clean room air filters are characterized and categorized by their anti particulate abilities and their air flow rates. For all cleanrooms that require class 100 or below, it is recommended that the controlled environment utilizes HEPA filtration units for the entire space.
Laminar Air Flow Products
Laminar air flow is the movement of air at the same speed and in the same direction, taking place along constant streamlines; not turbulent. Laminar air runs parallel with no cross over of airstreams. In contrast with laminar airflow, turbulent air flow is...
DIY Clean Room Environment
Cleanroom projects require several skill sets and knowledge experts to achieve a successful implementation, thus proving that a DIY clean room project is not the best means to a successful end. The Clean room project is closely managed and a site superintendent or project manager must be on the project from start to finish.
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.