Standards

Biopuremax & Regulatory Authorities:
Pharmaceutical plants usually struggle with the question “what is the right pharmaceutical water treatment for us and also how to choose the right pharmaceutical water system design for reliable operation and easy validation”.
Biopuremax is the house for all those services and supplies pharmaceutical water systems from A’-Z’, starting from the conceptual design and all the way through the detailed design, fabrication, programming, installation, commissioning, validation, project management and after sales services with cutting edge technology to the highest level of international standards.
Biopuremax technologies ESR™ and HOD™ are included in the upcoming PW/WFI water production ISO standards. In addition it is one of the only pretreatment systems that can produce WFI pharmaceutical grade water reliably without distillation.
The Biopuremax purified water systems comply with all the strictest requirements and standards of the industry for pharmaceutical water systems including:
EU cGMP
FDA cGMP
United States Pharmacopeia, USP PW
European Pharmacopoeia, PW
ASME BPE-2014
21 CFR part 11 / Annex 11
GAMP 5
21 CFR part 210: cGMP in manufacturing, processing, packing and holding of drugs
21 CFR part 211: cGMP for finished pharmaceuticals
FDA industry guideline: cGMP Guideline of inspection of preparation and drug manufacturer
EU-GMP-Guideline Part 1, Annexes 1, 15 & 17
Medicines and Healthcare products Regulatory Agency (MHRA)
ISPE Pharmaceutical Engineering Guide, Volume 4: Water and Steam Systems
ISPE Pharmaceutical Engineering Guide, Volume 5: Commissioning and Qualification
TEMA

Quality standards:
CE Mark
ISO 13475
ISO 9001