We want to use Gypsum Board as a false sealing material in pharmaceutical production area (ISO Class-D). Is their any guideline according to cGMP or ISO about Gypsum board use in Production area?
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Experiance will come with time, but you have to manage quality time. Bad management always leads us bad experiance.
Class action lawsuits are said to have been brought against those involved in the sale of gypsum boards made in China and which have been identified as the source of out-gassing of corrosive vapors. Some are said to be so pervasive as to corrode copper plumbing and air conditioning coils.
Given the nature of your work and the sensitivity to Federal regulatory agencies, it may prove worthwhile to make certain that the brand of material chosen is not amongst those identified in civil actions.
Or to skirt the problem completely by selecting an alternative product.
L.G.
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"Both the revolutionary and the creative individual are perpetual juveniles. The revolutionary does not grow up because he cannot grow, while the creative individual cannot grow up because he keeps growing." Eric Hoffer
Gypsum board is not suitable for pharmaceutical production areas. If anything were to bump it, scratch it, etc. it would at least scratch it, puncture it, break it all releasing dust particles which could be conveyed into the product. This would be by way of airborne transfer, conveyed by personnel or equipment which became contaminated with the dust or just simply fall into the products.
Other suitable materials are more readily available such as metal, glazed tile, epoxied metal, stainless steel, and many others.
On a list of suitability for this use, gypsum board would be so low that it wouldn't even make it on the list. At least over 40 years ago when I worked in the pharm. manufacturing industry we used epoxy painted metal, stainless steel, glass, Lucite, glazed tile for all surfaces including office areas in order to prevent the generation or transfer of particulates.
Good Luck, Old Salt
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