Call us: +49 (0) 7121 14 53 210
GMP cleanrooms for
pharma & medical technology
Be on the safe side
with your production
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.
Take 2 minutes to make a cleanroom enquiry now
Always individual, personal, competent and without obligation.
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
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
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
Frequently asked questions about GMP cleanrooms
What does GMP mean?
In which industries is cleanroom technology used?
What does the cleanroom class depend on?
What has to be considered in the production of medicinal products?
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.
Be on the safe side
with your production
Tailor-made GMP cleanrooms in a modular system for the pharmaceutical & medical technology industries
These companies rely on us
GMP cleanrooms in the pharmaceutical industry
Which standards and guidelines must be observed?
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.
Tailor-made cleanrooms for
pharmacies and laboratories
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.
MODULAR CLEANROOMS FOR MEDICAL TECHNOLOGY
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.
Take 2 minutes to make a cleanroom enquiry now
Always individual, personal, competent and without obligation.
Martin Hirlinger
General Manager
Phone: +49 (0) 7121 14 53 210
info@ap-systems.de