No.Test NameReference StandardAccreditedOut of Scope
1Bioburden TestTS EN ISO 11737-1+
2Pharmaceutical Product Bioburden TestEuropean Pharmacopoeia 2.6.12+
3Sterility TestTS EN ISO 11737-2+
4Pharmaceutical Product Sterility TestEuropean Pharmacopoeia 2.6.1, USP 71+
5Bacterial Endotoxin Test (LAL)EN ISO 11737-3, European Pharmacopoeia 2.6.14, USP 161, USP 85+
6Determination of Carbohydrate ResiduesPhenol–Sulfuric Acid Method+
7Determination of Protein ContentLowry Method+
8Determination of Hemoglobin ContentDrabkin Method+
9Accelerated Aging TestASTM F1980+
10Package Seal Strength TestISO 11607-1, ASTM F88/F88M, TS EN 868-5+
11Seal Integrity TestASTM F1929+