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Establishing Bioburden Alert and Action Levels

Most national and international standards regarding bioburden, sterilization, or environmental testing refer to establishing alert and action levels to assist in demonstrating continued control over a process or product. The standards sometime include guidance on evaluating the data but seldom go any further. Oftentimes, what information is provided in a standard is more descriptive rather than prescriptive, which is necessary in a national or international standard.



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Nelson Laboratories, LLC

http://www.nelsonlabs.com
E: [email protected]
T: (801) 290-7500
F: (801) 290-7998

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Espergaerde, Denmark
Aa. Louis-Hansens Alle 11
Espergaerde
3060
Denmark
T +45 (0) 49 12 79 72

Gibraltar Laboratories, Fairfield, New Jersey, USA
122 Fairfield Road
Fairfield, NJ
07004-2405
United States
T (973) 227-6882

Itasca, Illinois, USA
1500 W. Thorndale Ave
Itasca, IL
60143
United States
T (630) 285-9121

Mexico City, Mexico
James Watt No. 22
Cuautitlan Izacalli
Mexico
CP 54730
Mexico
T + 52 (55) 2620 9076

Nelson Labs Europe – Leuven, Belgium
Romeinsestraat 12
Leuven
3001
Belgium
T +32 (0) 16 40 04 84

Ontario, California, USA
687 S. Wanamaker Avenue
Ontario, CA
91761
United States
T (909) 969-2302

Petit Rechain, Belgium
Zoning Industriel
Avenue André Ernst 21
Verviers
4800
Belgium
T +32 (0) 87 30 70 63

Rantigny, France
8 rue Parmentier
Rantigny
60292
France
T +33 (0) 3 44 73 88 42

Shanghai, China
No 588, Chuan Tu Road, Chuan Sha
Pudong
Shanghai
201202
China
T +86 (21) 6828 0215

Somercotes, UK
Cotes Park Estate Somercotes
Alfreton
Derbyshire
DE55 4NJ
United Kingdom
T +44 (0) 1773 543 257

Wiesbaden, Germany
Kasteler Strasse 45 Gebäude
Wiesbaden
G525 65203
Germany
T +49 611 880 46 134

 
 
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