Types and Qualification of Passbox used in Pharmaceutical Industry

Introduction to Types & Qualifications of Passbox

A passbox is a device that is commonly used in the pharmaceutical industry to transfer materials between two separate environments with different cleanliness levels, such as from a higher classified cleanroom to a lower classified area. There are several types of passboxes that are commonly used in the pharmaceutical industry, including:

  1. Static Passbox: A static passbox is a simple design that features an interlocking system allowing only one door to be opened at a time. It is suitable for transferring non-contaminated items between areas of different cleanliness levels.

  2. Dynamic Passbox: A dynamic passbox has a more complex design and is equipped with a HEPA filter to ensure sterile air circulation during material transfer. It is typically used for the transfer of sterile products or components.

  3. Reverse Flow Passbox: A reverse flow passbox is designed to prevent cross-contamination between cleanrooms by using a negative pressure differential to draw air away from the cleanroom and towards the dirty room. This type of passbox is particularly useful when dealing with hazardous materials.

In terms of qualification, passboxes must meet certain standards and guidelines to ensure their effectiveness in maintaining cleanliness in the pharmaceutical manufacturing process. Some common qualifications for passboxes include:

  1. Installation Qualification (IQ): IQ ensures that the passbox is installed correctly and meets all engineering and design specifications.

  2. Operational Qualification (OQ): OQ checks that the passbox functions as intended and meets performance criteria.

  3. Performance Qualification (PQ): PQ tests the passbox under real-world conditions to ensure it can maintain cleanliness levels and prevent contamination.

Overall, passboxes play a critical role in maintaining cleanliness and preventing contamination in the pharmaceutical industry.

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Types and Qualification of Passbox used in Pharmaceutical Industry
Administrator December 22, 2023
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