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system for multi-use areas, especially if several products are processed simultaneously, should be assessed for potential cross-contamination.


Controlled Environment A controlled environment may be necessary to avoid contamination or degradation caused by exposure to heat, air or light. The degree of protection required may vary depending on the stage of the process.

Special environments required by some processes should be monitored to assure product quality (for example inert atmosphere or protection from light). Where an inert atmosphere is required, the gas should be treated as a raw material. If interruptions in the special environment occur adequate evidence and appropriate rationale should be documented to show that such interruptions have not compromised the quality of the excipient. Such environmental concerns become increasingly important following purification of the excipient.


Cleaning and Sanitary Conditions Adequate cleanliness is an important consideration in the design of excipient manufacturing facilities. Buildings used in the production, processing, packaging or holding of an excipient should be maintained in an appropriately clean and sanitary condition according to the type of processing conducted (for example open/closed systems).

Where maintenance of clean and sanitary conditions is critical to excipient quality, documented procedures should assign responsibility for cleaning and sanitation, describing in sufficient detail the cleaning schedules, methods, equipment and materials to be used in cleaning the buildings and facilities. These procedures should be followed and cleaning should be documented.

Waste should be segregated and disposed of in a timely and appropriate manner. If waste is not disposed of immediately, it should be suitably identified.


Pest Control Buildings should be free from infestation by rodents, birds, insects and other vermin.

Some raw materials, particularly botanicals, may contain some unavoidable contamination, such as rodent or other animal filth or infestation. The manufacturer should have sufficient control methods to prevent the increase of such contamination or infestation in holding areas and its spread to other areas of the plant.


Lighting Adequate lighting should be provided to facilitate cleaning, maintenance and proper operations.


Drainage In areas where the excipient is open to the environment, drains should be of adequate size and, where connected directly to a sewer, should be provided with an air break or other mechanical device to prevent back-siphoning.

Copyright © 2006 The International Pharmaceutical Excipients Council and Copyright © 2006 Pharmaceutical Quality Group

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