PDA Technical Glossary
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PDA Technical Glossary

PDA Technical Reports are highly valued membership benefits because they offer expert guidance and opinions on important scientific and regulatory topics and are used as essential references by industry and regulatory authorities around the world. These reports include terms which explain the material and enhance the reader’s understanding.

The database presented here includes the glossary terms from all current technical reports. The database is searchable by keyword, topic, or by technical report. Each definition provided includes a link to the source technical report within the  PDA Technical Report Portal.

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Sterile Processing GMP/Good Manufacturing Processes/cGMP TR 29: Validation: Cleaning
Acceptance Limit
The maximum amount of residue allowed in a product, in an analytical sample, or as an amount per surface area. (TR29)
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Coupon
A small, generally flat portion of a defined material of construction (such as stainless steel or PTFE) and of a defined surface finish, typically used for laboratory cleaning evaluations and/or for laboratory sampling recovery studies. (TR29) (TR49)
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Dirty Hold Time
The time from the end of product manufacturing until the beginning of the cleaning process (also called “soiled hold time”). (TR29)
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Limit
A value for a residue above which a cleaning process would not be acceptable. (TR29) A value for a residue above which a cleaning validation protocol would fail. (TR49)
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Mock Soil
A soil which is used in place of the manufactured product during a cleaning validation protocol (also called a “surrogate” soil). (TR29)
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Mock Soiling
A process of soiling the equipment for a cleaning validation protocol in which soil is applied to the equipment surfaces to simulate the condition of the soil on those surfaces following typical product manufacturing. (TR29)
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Product Changeover
Procedural steps taken for switching from the manufacturing of one product to another product. (TR29)
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