Hello good people of the world! Today’s post is the third in the series covering the commissioning, qualification, and validation of facilities, systems, and equipment involved in the manufacture of oral solid dose (OSD) products. This post covers the equipment used to manufacture these products.
Considerations include: materials of construction, sampling, and cleanability.
- Materials of Construction: it is critical that equipment materials do not react with or otherwise adulterate the product being manufactured. Materials of construction may be metals (e.g. 316L stainless steel), plastics, or elastomers. Other considerations include design documentation, surface finish including at welds, and any certification required.
- Sampling: equipment must be designed so that sampling is facilitated where required. Sampling is typically a mitigation for product quality failure modes such as content uniformity in granulation, over/under drying in drying, failed particle size distribution in milling, leakage in encapsulation, and over spray in coating, among others.
- Cleanability: automated clean-in-place (CIP) cleaning procedures are preferred where practical. Manual cleaning and sterilization may also be considerations.
What do you think about in terms of your OSD manufacturing equipment?
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