New October, 2011 – BioLumix Rapid Method Test System - Micro Results within 48 Hours!

Sampling and Testing of:

• Raw Materials/Chemicals
• Bulk Solution Batches & Finished Product Lots
• Manufacturing & Filling Equipment Cleaning Validations
• Customer Supplied Bulk Solution
• Water System

Note:  Sampling of raw materials & bulk solution containers is performed in a Sampling Booth equipped with a certified HEPA filter.

USP/AATCC Tests:

• In Compliance with Current Harmonized USP - Sections 61, 62

Performance of:

• Bioburden Testing
• USP Antimicrobial (Preservative) Efficacy/Effectiveness Testing
• Micro Test Method Validation
• Environmental Monitoring
• Dose Audits – for Gamma Sterilized Finished Products
• Autoclave (cycle) Validations, Mapping

Identification of Organisms Using:

• Selective Media
• Gram Stain using Microscope
• Biochemical Tests
• For Critical I.D.’s:  Biolog System – new 2007 ! (ID to Species Level)

Media:

• Media & Agar – purchased or made in-house
• Growth Promotion Testing - performed on each cycle of media sterilized and each lot of purchased media
• Sterility Testing performed on each cycle of media sterilized