Procedures manual, containment facility

EPA 1984. US Environmental Protection Agency Report EPA 520/5-884-006. Eastern Environmental Radiation Facility Radiochemistry Procedures Manual. Washington, DC EPA. An index to the procedures contained in this manual is available online at www.epa.gov/region01/oarm/testmeth.pdf. 

The first edition of an operating manual often contains excessive technical information because it is written while the facility is still in the design or constmction phase. These procedures are typically written by design engineers who know the process and equipment but who do not necessarily have much operating experience. Hence they may describe the material of construction and the design parameters of a pump in some detail, but provide little or no information on how to actually operate that pump. 

By analogy to solvent extraction, the column containing the solid adsorbent corresponds to the separatory funnel containing the immiscible organic solvent. The transfer of the solute to the solid adsorbent occurs in an unattended operation requiring no manual effort or additional equipment such as the shakers used in solvent extraction or the distillation apparatus used in some of the automatic extraction devices. This simplicity allows for facile automation either off-line or on-line with the separation and detection procedure (495, 512, 536). 

Published literature (e.g., textbooks and manuals) may be referenced in an SOP or may be used as a supplement to an SOP. However, published literature alone does not completely address the specific needs of a group or facility. Publications usually contain more information than is appropriate and are not clear enough in specifying which procedure to use. 

Quality manual (see Sect. 35.6.1) the quality manual describes the quality system of the pharmacy. It sets out the structure of the organisation, the responsibilities, the policy and the facilities of the pharmacy, such as rooms and equipment. It contains an overview of all procedures in use. Some procedures may form a part of the quality manual themselves. 

Utility systems such as water for injection (WFl). clean steam, clean-in-placc (CIP) solutions and sterile process air must be similarly proven. Also the building system itself has to be validated. Many bioprocess operations which contain potentially hazardous materials are operated in closely-controlled negative pressure enclosures with filtration of exhaust ventilating air. Sterile and particularly parenteral products arc processed in clean rooms which are maintained at positive pressure with filtered incoming air. Validation of building control systems and of personnel changing facilities and systems of work are necessary to meet CMP requirements. Manuals for formal test procedures are required to validate these activities. 

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