Quality Control

The QC Team maintains the air quality environmental testing program for all classified operating spaces, USP Water testing and clean steam testing. Sampling is performed in active areas weekly and as a part of the change over procedure. These programs are supported by performing routine microbiological assays, bioburden testing, conductivity, TOC, endotoxin. Air quality standards are applied to viable and nonviable air quality samples.

The QC Team also performs sampling for the raw material testing program. The majority of raw material samples are sent to qualified contract laboratory for analysis. We can perform ID or full compendia testing.

Instrumentation in the QC laboratory has been qualified prior to use for sample analysis. Test methods are documented in Standard Operating Procedures. Client provided test methods are transferred into the QC laboratory following a formalized process that is approved by quality assurance and the client. Method transfer includes specificity, precision and sample stability testing.

Test methods are qualified or validated to the level required by the intended use of the test method. Method qualification includes linearity, accuracy, precision and selectivity (stability indicating properties).

QC Laboratory Equipment

Environmental Monitoring Devices

pH/Conductivity Meter

TOC analyzer

Endotoxin tester

Milliflex unit for Bioburden

UV/VIS spectrophotometer

Assays Supported

Endotoxin

TOC

Microbial

Viability

Bioburden

Purity

HPLC (client specific methods)

Gas Chromatography

Protein Concentration

Filter Integrity

ELISA (client specific methods)

SDS Page

Western Blot

pH

Osmolarity

Conductivity

Capillary electrophoresis

Residual Testing

Host Cell Protein

Host Cell DNA

Protein L

Benzonase

Detergent

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