WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 14): Sterile Pharmaceutical Products: Sterile Production

WHO Basic Training Modules on Good Manufacturing Practices (GMP) - Basic Principles of GMP: Module 1 (Part 14): Sterile Pharmaceutical Products
(2006; 62 pages)

Table des matières

	Basic Principles of GMP
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production
	Sterile Production

Sterile Production

Premises (continued)

In clean areas, all exposed surfaces (2)

- proper installation of pipes and ducts, no recesses, no unsealed openings

- sinks and drains avoided, and excluded in Grade A and B areas

- where installed, design, location, maintenance

- effective cleanable traps

- air breaks preventing backflow

- floor channels open and easily cleanable

Wherever possible, pipes and ductwork should be outside the area, or boxed in.

Sinks and drains should be avoided if possible and must not be installed in aseptic areas. Drains should have cleanable traps and air breaks to prevent back flow. Floor channels must be open and easy to clean.