GxP Compliance & Testing

GXP Compliance & Testing, Inc.

GXP Compliance & Testing, Inc. provides steam quality and sterilization systems testing within the pharmaceutical and healthcare industries.

Established in 1996, our contract testing services include extensive knowledge and experience with the systems, sampling & testing equipment and methodologies needed for achieving and maintaining steam quality and sterilization quality standards.  Our methods ensure accurate test results, conclusions and recommendations.

GXP supports client compliance in these quality standards within the U.S. FDA Code of Federal Regulations Title 21 Sections 210-211 concerning drug manufacturing and processing and Section 820 concerning medical devices.  We also are adept in sampling and testing associated with meeting current European Standards EN 285 concerning sterilization, steam sterilizers and large sterilizer equipment.

gxp-compliance-and-testing-steam-systems

Preferred Pharma Vendor

GXP Compliance & Testing, Inc. is an owner-operator contract vendor serving select pharmaceutical industry clients.  

We provide unparalleled quality of service.  As an owner-operator company, all sampling and testing is performed first-hand.  With industry-specific knowledge and experience gained over decades of service, GXP is trusted by clients with the most demanding performance and regulatory compliance requirements.

Take Advantage of Highly-Skilled 24/7 Onsite Services.

GXP Compliance & Testing supports critical lights-out 3-shift production schedules typical in the pharmaceutical industry.  We will perform sampling and testing services according to your schedule – not ours – whether weekday, weekend or evening.

GXP Key Pharma Services

Talk with us about sampling and testing equipment requirements you may have for onsite testing.  We stock select testing equipment. 

We are currently in stock on Sampling Elbows

GXP Compliance & Testing, Inc.

Trusted By Leading Pharmaceuticals Companies

GXP Compliance & Testing has been a trusted and preferred contract testing vendor to leading Pharma corporations for decades.

Steam Quality - Sampling & Testing

Saturated and Superheated Steam Evaluation

GXP Testing & Compliance provides sampling and testing of saturated and superheated steam systems associated with required sterilization processes in pharmaceuticals manufacturing and production.

Our testing ensures our clients produce and deliver steam quality – in temperature, dryness, non-condensable gases – specified in EN 285 [European Standards Large Steam Sterilizer] and sterilization equipment manufacturer specifications.

The specialized equipment we utilize for for sampling and testing conforms with methodology referred to in ASTM Standards Vols 11.01 and 11.02, relating to water.

gxp-compliance-and-testing-autoclaves

Smoke Studies

Laminar Air-Flow Visualization

GXP Testing & Compliance performs smoke studies for our clients.  We are equipped with the instrumentation and methodology to perform onsite test at any time of the day or night – according to your requirements.

We conduct effective smoke studies to analyze laminar air-flow performance within laboratory clean room environments as well as biological safety cabinets.  Our testing ensures properly calibrated uni-directional air movement and flow performance.

As a primary service offered, GXP has been performing smoke studies for decades ensuring you receive accurate test results and recommendations where equipment modifications may be required.

Smoke Study Demonstration Video

GXP Compliance & Testing, Inc. laminar flow hood smoke test being conducted onsite in a client facility.