The suitability of electric versus hydraulic machines for cleanroom production has been hotly debated. Those in favor of electric machines point to the potential for hydraulic fluid to contaminate ...
Microtest Laboratories (Agawam, MA) has increased staffing in an effort to expand its contamination and cleanroom testing services. By assisting manufacturers to identify, assess, and resolve a range ...
Today’s standards define airborne particle monitoring in units of particles per cubic meter (particles/m 3). These standards tend to require sampling an entire cubic meter (1 m 3) to establish an ...
To guarantee the safety and efficacy of products manufactured in cleanroom environments, organizations such as International Organization for Standardization (ISO) and regulatory bodies such as the ...
The heart of cleanroom technology is the High Efficiency Particulate Air (HEPA) and Ultra Low Particulate Air (ULPA) filters that trap particles as small as 0.3 microns with an efficiency of 99.99%.
Presently, NEBB is collaborating with the American National Standard Institute (ANSI) to issue a fourth edition of the CPT as an ANSI standard. The environmental requirements for cleanrooms have ...
In line with the exceptionally high particulate and filmic cleanliness requirements that have to be met for high-tech components in an ever-increasing number of industries, acp systems AG has extended ...
The United States Pharmacopeia (USP) and others, such as EP, JP, and ChP, have developed test techniques to ensure that particle counts are kept to a minimum in intravenous injections (parenteral ...
Despite their frequent interchangeable use, understanding the distinction between validation and qualification is critical in pharmaceutical environments. Validation is a broader concept encompassing ...
The pharmaceutical and biopharmaceutical industries continue to embrace the utilization of single-use systems (SUS). With the ever-growing adoption of SUS products, increasing scrutiny has been placed ...