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STANDARD HYGIENIC PRACTICES FOR
DRY CHEMICAL HANDLING/PHARMACEUTICAL
The old Latin town
of Sermoneta is perched on foothills above what once was a large unhealthy
swamp, some 80 km south of Rome. A sleepy castle - where Bonifacius VIII
once lived - looks down on a fertile valley and a spacious, modern
manufacturing plant that produced 1850 tons of antibiotics last year.
It is the largest
such facility in the world: Bristol-Meyers Squibb S.P.A. uses it to
produce approximately 15% of the world's total consumption of penicillins
and cephalosporins.
And Tyvek® is there
to help them do it.
Not all
antibiotics are alike
When Fleming first
recognized the bactericidal properties of penicillin he started a
pharmaceutical arms race. New antibiotic defenses were constantly required
to keep up with mutant bacteria that had acquired immunity against
existing products. Today, Bristol-Meyers, Squibb S.P.A.'s Sermoneta plant
produces 15 mainstream antibiotics in bulk quantities. Seven of these are
penicillin derivatives, the other eight are cephalosporins - remotely
similar mold-based antibiotics with low toxicity and high bactericidal
activity.
Any contamination of
the antibiotics with germs spread by one of the plant's operatives could
have terrible consequences: all product must be sterile and it must be
packed under aseptic conditions. Bristol-Meyers Squibb S.P.A. subscribes
to the G.M.P. (good manufacturing practices) of the most advanced European
pharmacopoeias. The Italian and British Ministries of Health and the
American Food and Drug Administration make sure that their standards are
also rigorously adhered to.
Clean rooms and
separate lines
Fully separate
production lines for bulk chemical production and for packaging are used
in order to meet all requirements. Critical operations take place in
extraordinarily spacious "class 100" cleanrooms (where the number of dust
particles of 0.5 µm diameter or more must be fewer than 100 per cubic
foot).
No cost or effort is
spared to achieve optimal cleanliness: selection of materials and
equipment, airlocks, special entering procedures and a host of other
measures. For example, the manufacturing area as well as the environment
are protected with high efficiency ("total") filtration of the incoming
and outgoing air streams. The cleanrooms themselves are maintained under
overpressures ranging from 1.2 to 6 mm of water - the higher pressures
being applied to the more critical areas in order to "wash" contamination
away from them with a steady flow of freshly filtered air. In highly
critical areas the air may undergo as many as three complete changes per
minute requiring special care to ensure that the airflow remains non-
turbulent.
All these measures
would not be highly effective if they could not be matched with adequate
apparel to protect these high-performance cleanrooms from their occupants.
Key to achieving this protection are Tyvek® limited use garments.
The garments are
pre-sterilized before use. Since sterility on the outside can no longer be
guaranteed once the wearer takes the garment off, these Tyvek® garments
are discarded upon leaving the cleanroom after each continuous use cycle
(normally 3 to 4 hours).
The Tyvek® base
material used for these garments is extremely uniform and filters out more
than 98% of all particles 0.5 µm or over. It effectively keeps skin debris
and germs, shed by the wearer, from escaping into the cleanroom
environment. Tyvek® is also highly resistant to pilling and its smooth
surface does not add contamination of its own.
Bristol-Meyers
Squibb S.P.A. first started using garments made from Tyvek® in the early
eighties. Over the years, Tyvek® garments have contributed significantly
to a reliable and consistent operation, comfortably within specifications.
And, above all, to
healthy antibiotics - free of germs or other contaminations.
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