Procedure and Protocol
ISO 13485 is designed for use throughout the life cycle of a medical device. It supports each stage of medical device development and operation from initial concept to production and disposal. The standard helps internal and external parties certify and validate processes which maintain the stability of quality management systems (QMS).
Are the terms sterile and aseptic used interchangeably? Is a cleanroom sterile? What is aseptic processing?
Facilities unpacking hazardous drugs within a negative pressure room do not require procedural changes to meet USP unpacking area requirements. Facilities unpacking HDs within positive pressure ante rooms or facility spaces will require reconsideration.
This guide provides a framework for employees entering a cleanroom.
Proper cleanroom cleaning procedure and maintenance protocol is an immediate, low-cost measure to enhance overall cleanliness, consistency, and contamination control within manufacturing and aseptic cleanrooms. This guide provides a framework for cleanroom management, protocol standards, specifications, and processes for general manufacturing and bio-medical applications.
Learn how to properly mop a cleanroom for ISO class or cGMP cleanliness levels. Compare designs and materials of multi-bucket cleanroom mop systems.
What’s the difference between a woven and non-woven cleanroom wipe? What’s the right wipe for ISO class 3 or ISO class 8 compliance?
How to Certify a Cleanroom with Kanomax Hand Held Particle Counters
High-traffic cleanrooms use tightly controlled procedures with repeatable processes to maximize the passage of people in and out of sanitary environments. Cleanroom facilities of all
1. Ignoring the Need to Wipe on a Regular Basis To assure quality is maintained in all cleanroom and restricted areas, housekeeping maintenance must be
Article reprinted from Clean Air Products, manufacturers of air showers, cleanrooms, and cleanroom accessories. A cleanroom provides a controlled environment in which companies can produce
Read the complete guide to decontamination and disinfection of biological safety hoods and cleanroom isolators for pharmaceutical production and laboratories.