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PKP Notes

Cleaning validation repeated every year on one batch (started with 3 batches). Minimal interventions during the 1 hour interval not specified in the procedure for media fills. Leaktest: IPQC leak test with methylene blue each half hour during production. After completion of leak test: Complete batch of product is tested for leakage of the vials by running an autoclave cycle under pressure for 15 mins at room temperature. Dosage in FP is done by potentiometry. E) Easy sealing of utility penetrations.

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PKP Notes | pkpnotes.blogspot.com Reviews

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Cleaning validation repeated every year on one batch (started with 3 batches). Minimal interventions during the 1 hour interval not specified in the procedure for media fills. Leaktest: IPQC leak test with methylene blue each half hour during production. After completion of leak test: Complete batch of product is tested for leakage of the vials by running an autoclave cycle under pressure for 15 mins at room temperature. Dosage in FP is done by potentiometry. E) Easy sealing of utility penetrations.

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2 simply note taking

3 posted by kamal

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PKP Notes | pkpnotes.blogspot.com Reviews

https://pkpnotes.blogspot.com

Cleaning validation repeated every year on one batch (started with 3 batches). Minimal interventions during the 1 hour interval not specified in the procedure for media fills. Leaktest: IPQC leak test with methylene blue each half hour during production. After completion of leak test: Complete batch of product is tested for leakage of the vials by running an autoclave cycle under pressure for 15 mins at room temperature. Dosage in FP is done by potentiometry. E) Easy sealing of utility penetrations.

INTERNAL PAGES

pkpnotes.blogspot.com

1

PKP Notes: FDA Guidance for Industry - Process Validation: General Principles and Practices

http://pkpnotes.blogspot.com/2011/02/fda-guidance-for-industry-process.html

FDA Guidance for Industry - Process Validation: General Principles and Practices. FDA Guidance for Industry - Process Validation: General Principles and Practices. Subscribe to: Post Comments (Atom). FDA Guidance for Industry - Process Validation: Ge. WHO QA Topics and Guidelines. Awesome Inc. template. Powered by Blogger.

2

PKP Notes: Simply Note Taking

http://pkpnotes.blogspot.com/2011/06/simply-note-taking.html

Cleaning validation repeated every year on one batch (started with 3 batches). Minimal interventions during the 1 hour interval not specified in the procedure for media fills. Leaktest: IPQC leak test with methylene blue each half hour during production. After completion of leak test: Complete batch of product is tested for leakage of the vials by running an autoclave cycle under pressure for 15 mins at room temperature. Dosage in FP is done by potentiometry. Subscribe to: Post Comments (Atom).

3

PKP Notes: February 2011

http://pkpnotes.blogspot.com/2011_02_01_archive.html

FDA Guidance for Industry - Process Validation: General Principles and Practices. FDA Guidance for Industry - Process Validation: General Principles and Practices. Subscribe to: Posts (Atom). FDA Guidance for Industry - Process Validation: Ge. WHO QA Topics and Guidelines. Awesome Inc. template. Powered by Blogger.

4

PKP Notes: Selecting a Pharmaceutical Manufacturing Suite Wall Finish System; A Field Study

http://pkpnotes.blogspot.com/2011/01/selecting-pharmaceutical-manufacturing.html

Selecting a Pharmaceutical Manufacturing Suite Wall Finish System; A Field Study. Selecting a Pharmaceutical Manufacturing Suite Wall Finish System; A Field Study. One of the key issues that must be considered in either the new construction or remodeling of existing pharmaceutical manufacturing suites is the selection of a durable wall finish system. The selected system must have the following characteristics;. A) Ability to withstand high pressure detergent washing. The most durable manufacturing suite ...

5

PKP Notes: June 2011

http://pkpnotes.blogspot.com/2011_06_01_archive.html

Cleaning validation repeated every year on one batch (started with 3 batches). Minimal interventions during the 1 hour interval not specified in the procedure for media fills. Leaktest: IPQC leak test with methylene blue each half hour during production. After completion of leak test: Complete batch of product is tested for leakage of the vials by running an autoclave cycle under pressure for 15 mins at room temperature. Dosage in FP is done by potentiometry. Subscribe to: Posts (Atom).

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PKP Notes

Cleaning validation repeated every year on one batch (started with 3 batches). Minimal interventions during the 1 hour interval not specified in the procedure for media fills. Leaktest: IPQC leak test with methylene blue each half hour during production. After completion of leak test: Complete batch of product is tested for leakage of the vials by running an autoclave cycle under pressure for 15 mins at room temperature. Dosage in FP is done by potentiometry. E) Easy sealing of utility penetrations.

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