Post-Sterilization Tests

Ethylene Oxide Residues Tests – ISO 10993-7 Standard
Ethylene Oxide Residual Analysis (EO only)

• Aqueous Extraction
• Headspace Sampling
• Acetone or DMF Extraction

Ethylene Chlorohydrin Residuals Analysis (ECH only)

EO and ECH (aqueous extraction of EO residue)
(covers all ISO patient exposure categories)
EO Dissipation Studies

LAL Bacterial Endotoxins Tests – USP
Gel Clot Method

• Water
• Liquids
• Powders
• Medical Devices (Immersion, < 1000 mL LAL negative water)
• Medical Devices (Immersion, > 1000 mL LAL negative water)
• Medical Devices (Fluid Path, < 1000 mL LAL negative water)
• Medical Devices (Fluid Path, > 1000 mL LAL negative water)
• Concurrent Assay of Sample Dilution
• Non-concurrent Assay of Sample Dilution

*The gel clot method is semi-quantitative. For medical devices produced in lots of greater than 100 units, 10 samples are required. One test is performed on a composite of the 10 samples. Typically, the sample composite is tested at half of the client specified endotoxin limit. For cerebrospinal fluid contact, the average device limit in a 10 sample composite test is 2.15 endotoxin units (EU). For most other devices, the average limit in a 10 sample composite test is 20 EU per device. When successful, the interpretation for the test will be reported as follows: "These samples pass the test for bacterial endotoxins at 1/2 the endotoxin limit for medical devices." For liquid samples with an EU level below test system sensitivity limits, the results will be reported as "less than (the test system limit)", eg. 0.125 EU/mL for high purity water. If an exact EU result is required, a kinetic method must be used.

Kinetic Turbidimetric or Chromogenic Methods
For liquids and powders

• Medical Devices (Immersion, < 1000 mL LAL negative water)
• Medical Devices (Immersion, > 1000 mL LAL negative water)
• Medical Devices (Fluid Path, < 1000 mL LAL negative water)
• Medical Devices (Fluid Path, > 1000 mL LAL negative water)
• Concurrent Assay of Sample Dilution
• Non-concurrent Assay of Sample Dilution

*The kinetic test methods are quantitative. Generally, the resulting number of EU/mL determined in the test is reported. In some instances, a "less than detection limit quantity" may be reported.

LAL Validation – Inhibition and Enhancement
Gel Clot Method

• LAL Validation (one lot)
• LAL Validation (three lots, concurrently tested)

Kinetic Turbidimetric or Chromogenic Methods

• LAL Validation (one lot)
• LAL Validation (three lots, concurrently tested)