FDA/USP Status

March 15, 2019
FDA/USP Status
Cleaning Validation for Medical Devices: Establishing Cleaning Limits
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March 15, 2019
FDA/USP Status
FDA has finalized bioanalytical validation guidance
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March 15, 2019
FDA/USP Status
AET and Ophthalmic Drug Products
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March 15, 2019
FDA/USP Status
Update on the Status of USP <661.1> and <661.2>
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March 15, 2019
FDA/USP Status
USP <467> Residual Solvents Testing
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March 15, 2019
FDA/USP Status
USP <232>
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Recent Posts
January 7, 2020
Extractables and Leachables from Single Use Systems and Multi-Use Equipment Used in Pharmaceutical and Biotherapeutic Manufacturing
October 1, 2019
Extraction Study of a Cartridge Filter Based Upon the BioPhorum Operations Group (BPOG) Recommendation
June 10, 2019
Simulated Use Extraction as an Alternative to Leachables Testing
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Pine Lake Laboratories is a GLP/GMP compliant analytical and bioanalytical contract testing laboratory. Our lab, located in Bristol, CT, is FDA registered and inspected and DEA licensed for Schedules 1 through V.

High Quality Services
BPOG EXTRACTION STUDIES
Analytical Analysis of Antibiotic Coated or Loaded Surgical Implants
Extractables & Leachables
Analytical Testing of Combination Products
CMC Analytical Testing
Cleaning Validations For Medical Devices
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Recent Posts
January 7, 2020
Extractables and Leachables from Single Use Systems and Multi-Use Equipment Used in Pharmaceutical and Biotherapeutic Manufacturing
October 1, 2019
Extraction Study of a Cartridge Filter Based Upon the BioPhorum Operations Group (BPOG) Recommendation
June 10, 2019
Simulated Use Extraction as an Alternative to Leachables Testing
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