Vileda Nordic CE Product catalogue

GMP GOOD MANUFACTURING GUIDELINES GMP ANNEX 1 - CLEANING & DISINFECTION Mechanical cleaning programs should be effective in the removal of surface particles and residual disinfectant residues. Disinfectants and detergents should be regularly monitored for microbial contamination. Disinfection dilutions should be kept in clean containers and should only be stored for defined periods determined by the manufacturer. The disinfection of clean areas is particularly important. They should be cleaned and disinfected thoroughly in accordance with a formal contamination control program. For disinfection to be effective, mechanical cleaning to remove surface contamination must be performed first. GMP ANNEX 1 - EQUIPMENT The cleaning process should be validated to demonstrate that it; Can remove residues that would otherwise create a barrier between the sterilizing agent and the equipment surfaces Prevents chemical and particulate contamination of the product during the process and prior to disinfection. All critical surfaces that come into direct contact with sterile materials should be sterile We understand the challenges within the different standards and classifications required. Our systems and solutions have been designed to fulfill these challenges. To ensure standardized high quality results every time, we work according to international standards. As your cleaning partner, we must also follow compliance .

IEST INSTITUTE OF ENVIRONMENTAL SCIENCES & TECHNOLOGY IEST is the leading technical, non-profit membership association that connects professionals who impact the controlled environment industry. Founded in 1953, IEST is a multidisciplinary, international society with members who are internationally recognized for their contributions to the environmental sciences. They provide technical guidance through international standards, recommended practices, education programs developed by experts in the fields of contamination control, environmental testing, reliability and nanotechnology facilities. IEST’s 501(c)(3) none profit technical society is an ANSI accredited standards developing organization. It is also Secretariat of ISO/TC 209 cleanrooms and associated controlled environments. It is also an administrator of the ANSI accredited US TAG to ISO/TC 209. IEST is a founding member of the ANSI- accredited US TAG to ISO/TC 229 nanotechnologies.

CLEANROOM - CLASSES

18001:2007

14001:2015

ISO 50001

Current Standard

Prior Standard US Federal Standard 209E/D

DIN EN ISO 14644-1

EG/GMP

Maximum acceptable number of particles per cubic meter and particle size (cross section dimension) 0,1 µm/m3 0,2 µm/m3 0,3 µm/m3 0,5 µm/m3 1,0 µm/m3 5,0 µm/m3

KBE/m3t (colony forming units)

Cleanroom Class

Cleanroom Class

Metric SI- unit m3

English unit ft3

ISO 1 ISO 2 ISO 3 ISO 4 ISO 5 ISO 6 ISO 7 ISO 8 ISO 9

10

2

100

24

10

4

1000

237

102

35

8

M 1,5 M 2,5 M 3,5 M 4,5 M 5,5 M 6,5

1

10000

2370

1020

352

83

10

100000 23700

10200

3520

832

29

A/B

<1 10

100

1000000 237000 102000 35200

8320

293

(B)

1,000

352000 83200

2930

C

100

10,000 100,000

13

3520000 832000 29300 35200000 8320000 293000

(C)/D/E/F 200

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