Tailor-made GMP cleanrooms in a modular system for various industries
The requirements to be met by cleanrooms in the pharmaceutical, medical technology and healthcare sectors are demanding. Contamination with harmful particles or germs must be reliably eliminated at all times. With the production of medicinal products in a GMP cleanroom, you fulfil the legal requirements and are on the safe side.
Cleanroom for the Pharmaceutical Industry
Cleanroom for Medical Technology
Cleanroom for the Cosmetics Industry
Cleanroom for Pharmacies & Laboratories
Turnkey Cleanrooms in Accordance with GMP
Benefit from our expertise and tailor-made concepts
Are you legally bound to the GMP for your production in the pharmaceutical industry? Are airborne germs or particles a problem you want to avoid or must avoid?
We will advise you comprehensively on the possibilities of a GMP cleanroom that is individually tailored to your industry and environment. We take into account the currently applicable cleanroom classes with the admissible particle concentrations. GMP-compliant cleanrooms from ap-systems separate sensitive production areas from other parts of the building.
A GMP Cleanroom Gives You Control Over
- the microbiological status
- the air purity in terms of particle concentration
- pressure
- temperature
- and other sensitive parameters
How Much Does a GMP Cleanroom Cost?
We will inform you of the costs in good time. Fair and transparent. We will be happy to provide you with an appropriate offer.
- Planning your GMP cleanroom
- Construction (production and assembly) of a GMP cleanroom
- Operation of cleanroom systems
- Coordinated ventilation and air-conditioning technology
What Do I Need to Take into Account When Manufacturing in a GMP Cleanroom?
Production in the cleanroom requires a high degree of discipline and a different approach to that found in conventional production processes. Compliance with the high quality standards requires:
- Know-how
- A well thought-out concept
- Coordinated methods and tools
- Appropriate behaviour of the employees
- Cleanroom clothing
Why Should I Enquire About a GMP Cleanroom From ap-systems?
A GMP cleanroom from ap-systems offers you:
- Cleanroom-compliant wall and ceiling system
- GMP-compliant ventilation and lighting units or door and window systems
- Modular cleanroom systems
- Customer-specific requirements such as material sluices or pass-throughs
Frequently Asked Questions About GMP Cleanrooms
GMP stands for “Good Manufacturing Practice”. This is understood to mean guidelines for quality assurance in the production of pharmaceuticals and active ingredients as well as in the manufacture of medical devices.
Cleanrooms according to GMP are common in the pharmaceutical industry, e.g. in the production of cytostatics, or in medical technology.
The cleanroom classes according to the EU GMP guidelines depend on the industry and the conditions under which production takes place. They are divided into cleanroom classes A, B, C and D. The most stringent requirements are specified for cleanroom class A. The maximum airborne particle count is lower than that for the other classes.
The manufacture of cytostatics is governed by the German Ordinance on the Manufacture of Medicinal Products and Active Pharmaceutical Ingredients (AMWHV). It implements the content of the GMP guidelines as laid down in Parts 1 and 2.
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EU GMP Guidelines (Also EC GMP Guidelines)
The standards and guidelines depend on the industries and their requirements. In principle, the EU GMP guidelines (also EG GMP guidelines) with their 3 parts and 18 annexes apply. GMP stands for “Good Manufacturing Practice”.
The Good Manufacturing Practice guidelines are mandatory for validation and quality assurance in the pharmaceutical industry. With a GMP cleanroom from ap-systems, you comply with the guidelines.
The GMP Guideline contains directives on quality assurance and cleanroom conditions for the production of:
- medical products
- cosmetics
- food
It defines limits for microbiological contamination (CFU) by microorganisms and for maximum particle levels in the air. The Good Manufacturing Practice Guide divides the ambient conditions into: Cleanroom class A, Cleanroom class B, Cleanroom class C and Cleanroom class D.
EU GMP Guidelines Annex 1
The EU GMP guidelines Annex 1 are relevant for the production of:
- medicinal products
- medications
- active substances such as cytostatics or parenterals
The EU GMP Guideline Annex 1 specifies the conditions to be observed in the laboratory or pharmacy during manufacture of medicinal products. The manufacture of medicinal products such as parenteral medicines or cytostatics must be aseptic, i.e. germ-free. According to the Pharmacy Ordinance, this is a pharmaceutical activity and is carried out by pharmacy personnel.
Do you produce medicinal products in a hospital pharmacy or do you work in a laboratory? In our cleanrooms for the pharmaceutical industry we take into account:
- Pharmaceuticals and Active Ingredient Manufacturing Ordinance
- GMP Guideline Annex 1
- Cleanroom classes A-D
Request a cleanroom offer now without obligation and secure your manufacturing of both medical and other pharmaceutical products.
EU GMP Guidelines Part 2
The EU GMP Guideline Part 2 is applicable to the manufacturing of medical technical products. It defines the standards under which medical technical products are produced.
- Are you a service provider in medical technology sector?
- Do you need a cleanroom that allows you to automate?
- You can safely automate the manufacturing of medical products in a modular GMP-compliant cleanroom system.