HVAC Design for Pharmaceutical Facilities – PDF download

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HVAC Design for Pharmaceutical Facilities

“CLEANLINESS, CLEANLINESS and CLEANLINESS”

In pharmaceutical manufacturing, how space conditions impact the product being made
is of primary importance. The pharmaceutical facilities are closely supervised by the U.S.
food and drug administration (FDA), which requires manufacturing companies to
conform to cGMP (current Good Manufacturing Practices). These regulations, which
have the force of law, require that manufacturers, processors, and packagers of drugs to
take proactive steps to ensure that their products are safe, pure, and effective. GMP
regulations require a quality approach to manufacturing, enabling companies to minimize
or eliminate instances of contamination, mix ups, and errors.
The GMP for HVAC services embraces number of issues starting with the selection of
building materials and finishes, the flow of equipment, personnel and products,
determination of key parameters like temperature, humidity, pressures, filtration, airflow
parameters and classification of cleanrooms. It also governs the level of control of
various parameters for quality assurance, regulating the acceptance criteria, validation of
the facility, and documentation for operation and maintenance.
Various countries have formulated their own GMPs. In the United States, it is regulated
by several documents such as Federal Standard 209, code of Federal regulations CFR
210 & 211 etc, which are revised and updated from time to time. The European
Community has a “Guide to Good Manufacturing Practice for Medicinal Products” and in
the United Kingdom it is BS 5295. The World Health Organization (WHO) version of
GMP is used by pharmaceutical regulators and the pharmaceutical industry in over one
hundred countries worldwide, primarily in the developing world. In some countries, the
GMP follows largely the country of the principal technology provider. All GMP’s have one
common theme……

“CLEANLINESS, CLEANLINESS and CLEANLINESS”

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