Good manufacturing practices ( GMP ) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages , cosmetics , pharm...
FDA Updates Guidance on Electronic Records, Signatures
After issuing its controversial Guidance forIndustry Part 11, Electronic Records;Electronic Signatures Scope and Application 1 20 years ago, the FDA struggled with consistentenforcement of the guidance. At the time, industrycountered with f...
Implementing Contamination Control for cleanrooms
A CLEANROOM CAN BE DEFINED as a high-tech, controlled environment where the concentration of airborne particles, humidity, and temperature are all controlled to parameters specified by the ISO 14644. As science progresses, the demand for cl...
What is Sustainable Packaging?
To understand what sustainable packaging is all about, we must turn to an organization called GreenBlue. This non-profit has taken a leadership role in promoting, among other things, the use of sustainable packaging materials internationall...
Laser Particle Counter Known Well Through ISO14644-2015 Stan
ISO 14644-2015 New Version ISO14644 consists of the following parts: Part 1: Classification of air cleanliness by particle concentration Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle...