Handbook of Pharmaceutical Manufacturing Formulations - by Sarfaraz K. Niazi

By Sarfaraz K. Niazi

content material: v. 1. Compressed stable items --
v. 2. Uncompressed good items --
v. three. Liquid items --
v. four. Semisolids items --
v. five. over the counter items --
v. 6. Sterile products.

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Extra resources for Handbook of Pharmaceutical Manufacturing Formulations - Sterile Products (Volume 6 of 6)

Example text

B. Inspection of Container/Closure System A container–closure system that permits penetration of air, or microorganisms, is unsuitable for a sterile product. Any damaged or defective units should be detected and removed during inspection of the final sealed product. Safeguards should be implemented to strictly preclude shipment of product that may lack container–closure integrity and lead to nonsterility. Equipment suitability problems or incoming container or closure deficiencies have caused loss of container–closure system integrity.

Direct inoculation into the drug formulation provides an assessment of the effect of drug product on the filter matrix and on the challenge organism. However, directly inoculating B. diminuta into products with inherent bactericidal activity or into oil-based formulations can lead to erroneous conclusions. When sufficiently justified, the effects of the product formulation on the membrane’s integrity can be assessed by an appropriate alternative method. For example, the drug product could be filtered in a manner in which the worst-case combination of process specifications and conditions is simulated.

When designing the validation protocol, it is important to address the effect of the extremes of processing factors on the filter capability to produce sterile effluent. 9–11 Filter validation experiments, including © 2004 by CRC Press LLC microbial challenges, need not be conducted in the actual manufacturing areas. However, it is essential that laboratory experiments simulate actual production conditions. The specific type of filter used in commercial production should be evaluated in filter validation studies.

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