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Tooling Storage: Ø Store Tooling in Dies & Punches room in designated racks with tooling storage rack label after applying a thin smear of lubricant oil over the punch and die surface. Ø Fill out a new Tooling Storage Rack Label for new set with the following information: a) Rack number b) Set Number c) Product name & Strength d) Punch dimensions e) Punch specification f) Tooling D/B/BB g) Quantity h) Embossing on Upper punch i) Embossing on Lower punch j) Checked by NOTE: For plain tooling, meaning there is no embossing on the face of the tooling, the word “plain” shall be noted. Ø Once all verifications are complete, ...

Cleaning Validation | Campaign Cleaning Validation (CCV)

By Unknown - September 01, 2016

When the product demand does not allow for a complete clean up after each batch, a campaign cleaning validation must be conducted. A back to back cleaning is performed between batches in a campaign, and a complete cleaning at the end of a campaign. Sampling of the equipment is performed after the last batch in a campaign, and all test results must meet predetermined acceptance criteria as per campaign cleaning validation protocol. Samples for residual active may be taken after back to back cleanings where possible, for information only . Microbiology samples may be taken after back to back cleanings in a campaign to ensure that there is no excessive microbial growth on the equipment.

Blending | Effective Sampling During Process Validation | Optimize Sampling Location

By Unknown - December 07, 2015

Important of sampling during blending: Sampling plays a great role in achieving the accurate results of analysis. Sampling must and procedure must be defined in validation protocols and training should be provided to the concerned staff before the validation activities start. Samples are representative of the whole batch. So it should be handled and weight carefully because segregation may occur during weighing and transpiration. Sample quantity should not be more than the required and whole mass sample should be used in the analysis. Fig: Blending Machine Sampling for blend: Blends are tested for their homogeneity. Homogeneity of the blend is critical for the quality of the final product. The sample should be taken from at least 10 locations in the blender. The sampling location should be selected according to the difficulty of the blending. Ares of poor blending must be covered in sampling. Corners and discharged point must have...

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