8.5.3
Other regulations and standards
Introduction
This section describes the standards that apply to the product.
Biological and chemical
compatibility
The Wetted parts of the product meet the material requirements of the following
standards and regulations:
Requirement
Description
USP <88> Class VI
Material requirements from United States Pharmacopeia.
Biological Reactivity Tests, "In Vivo".
21 CFR 177
Indirect food additives: Polymers
Additional design considerations
For additional design considerations, such as ASME-BPE, GMP and cGMPs information
refer to the product-specific specification information provided in the documentation
package delivered with each equipment.
8 Reference information
8.5 Regulatory information
8.5.3 Other regulations and standards
Chromaflow Packing Station 50, 100, 200, and 400 Operating Instructions 29046228 AD
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