PDA Journal of GMP and Validation in Japan
Online ISSN : 1881-1728
Print ISSN : 1344-4891
ISSN-L : 1344-4891
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Relationship between Deterioration of Bio-C.R. Garments and Frequency of Sterilization by Autoclave
Toshikatsu ASADAKouhei MORITAKazunori MIYAMOTO
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2001 Volume 3 Issue 1 Pages 28-32

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Abstract

  In pharmaceutical manufacturing process, the contamination of particulate into drugs is a very important issue because of the adverse impacts upon human health & medical treatment. 7 commercially available Bio-cleanroom garments were tested and evaluated for characteristics related both to functionality and to contamination, according to the frequency of their clean laundry & sterilization cycles. Results are as follows: (1) Self-particle generation level from Bio-C.R. garments is higher than ICR C.R. garments. (2) Bio-C.R. garments are highly deteriorated by sterilization (Autoclave) . (3) Bio-C.R. garments shall be designed (i) to reinforce the strength of horizontal yarn, (ii) to weave high density of filaments by twill structure, (iii) to install E.C.F into a fiber by stripe, (iv) to make of plastic materials for zipper, (v) to make of plastic materials for Velcro fastener. (vi) to separate hood from C.R. garment itself.

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© 2001 Parenteral Drug Association Japan Chapter
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