Cleanrooms

in Pharma

Laboratory
Class C
Incoming
Airlock
Pre-Gowning Room
Class B

EU GMP
Good Manufacturing Practice
Deinition: a cleanroom is an environment, typically used in
the manufacturing of pharmaceutical products, with
a low level of environmental pollutants such as dust, airborne microbes, aerosol particles and chemical vapors.
A cleanroom has a controlled level of contamination
that is speciied by the number of particles at a speciied
particle size.
Example: an urban environment contains 35,000,000
particles of 0,5 m and larger in diameter per m, an ISO 5
cleanroom may only have 3,520 particles of 0,5 m.
Standards & Regulations: ISO 14644: standard for
airborne particulate cleanliness classes in cleanrooms
and clean zones.
ISO 14698: cleanrooms and associated controlled
environments Biocontamination control.
EU GMP annex 1: Manufacture of sterile medicinal products.

Gowning Area
Class B
Preparation Room
Class A

Dressing Bench

Class A

Exit Airlock
De-Gowning Room
Class B

Sterility Suite
Class A

Laboratory
Class C

Each Clean Room class has different limits

ISO, GMP and local Pharmacopoeias can have different limits
Ensure you check which limits you should be using
Product Category
Particle counting

Products
APC ErgoTouch Pro 2

Products for desinfection control

MQuant

Reflectoquant

MColortest

Spectroquant

http://www.emdmillipore.com/particle-counting
Active air
monitoring

Environmental monitoring of your typical

ISO 5 sterility suite:
Monitor with active viable and non-viable air samplers
and particle counter
Place settle plates (90 mm) in designed high risk sample
locations
Sample surfaces (loors, doors, walls, etc) with
ICR Contact Plates
Utilize ICR Swab for surfaces dificult to reach
Monitor personnel at the end of a production badge
The M mark is a trademark of Merck KGaA, Darmstadt, Germany. HYCON and RCS are registered
trademarks of Merck KGaA, Darmstadt, Germany. MAS-100 NT, MAS-100 Iso NT, MAS-100 Iso MH,
MAS-100 VF and MAS-100 CG Ex are registered trademarks of MBV AG Switzerland, www.mbv.ch.
Lit.No. PS5464ENUS 09/15
2015 Merck KGaA, Darmstadt, Germany. All rights reserved.

EMD Millipore Corp. is a subsidiary of Merck KGaA, Darmstadt Germany

MAS-100 Iso NT

MAS-100 NT

RCS High Flow Touch

MAS-100 CG Ex

ICRplus Contact Plates

HYCON agar strips for

RCS Air Samplers

MAS-100 Iso MH

MAS-100 VF

ICRplus Settle Plates

http://www.emdmillipore.com/active-air-monitoring
Passive air
monitoring

ICR Settle Plates

ICRplus Settle Plates

ICRplus Contact Plates

http://www.emdmillipore.com/passive-air-monitoring
Personnel
and surface
monitoring

ICR Swabs

ICRplus Settle Plates

http://www.emdmillipore.com/personnel-and-surface-monitoring

HYCON Contact Slides