Introduction to Barrier Isolator Regulations and Legislation
The Standard Group of Companies is a leading supplier of equipment in the pharmaceutical industry.
A key part of the process for many pharmaceutical applications is a barrier isolator.
The Schematic Engineering Industries division of the Standard Group, design, manufacture, install and commission standard and bespoke barrier isolators for all customer requirements.
In essence Barrier Isolators are extensively regulated with their design and operating performance, having to conform to strict international and client specific standards, guidelines and legislation.
Examples of Regulatory Environment standards, guidelines and legislation:-
Legislation: -
United States Pharmacopeia—National Formulary (USP 36-NF)
Chapter 71; Sterility testing
Chapter 1021; Barrier Technology
Chapter 1116; Microbiological evaluation of clean rooms
Chapter 1211; Sterilization and sterility assurance USP 29\1211
21 CFR (Code of Federal Regulations) Part 210, 211 (GMP)
21 CFR Part 11 (Electronic Records, Electronic Signature)
21 CFR 177.2410 (Phenolic resins in moulded articles)
Standards: -
EN ISO 13408-6: Aseptic Processes
SN EN ISO 14161 Biological indicators
EN ISO 14644 Part 1–8 Cleanrooms
EN ISO 14698-1 Cleanrooms
VDI 2083-16 Cleanroom technology and barrier systems
Cleanroom modules, effectiveness and certification
EN ISO 14698-2 Cleanrooms EN 1822 HEPA (definition and examination)
EN 13 824: Sterilisation of medical devices
EN 1274: Biotechnology
ISO 11138-1 Sterilization of Health Care Products—Biological Indicators
Guidelines: -
EU directives with legislative effect to the development and construction of isolators and RABS influence
GMP Directive (2003/94/EC)
Machinery Directive (2006/42/EC)
Electromagnetic Compatibility (2004/08/EG)
Low Voltage Directive (2006/95/EC)
The Standard Group of Companies are also leading experts in delivering a quality product, taking into consideration all legislation and regulations which gives all clients the confidence in the products they are using.
For more information click here or contact the UK and Indian offices direct.
