Pharmaceutical Testing
The leading global pharmaceutical manufacturers
use Celsis technology to detect low levels
of contamination in their products. Celsis
is the leader in gaining regulatory and industry
acceptance for rapid microbiology. Regulatory
Authorities and Industrial Leaders throughout
Europe and the United States have been introduced
to bioluminescence technology by Celsis.
|
|
RapiScreen™ Health
RapiScreen™ Health is the industry standard for rapid microbial detection in pharmaceutical products. Utilizing ATP Bioluminescence technology, RapiScreen provides results in 24 to 48 hours.
Celsis RapiScreen™ Health Brochure
RapiScreen™ Biologics
RapiScreen Biologics has been specifically designed
to address the needs for in-process testing in
the bioprocessing industry. This assay includes
an additional reagent, Celsis LuminASE™ Biologics,
which pretreats the sample to reduce non-microbial
sources of ATP allowing for a reliable and sensitive
screen for microbial contamination. RapiScreen
Biologics delivers results in 24 hours or less
depending upon requirements.
Celsis RapiScreen™ Biologics Brochure
AKuScreen™
AKuScreen™ offers
the latest technological advances in bioluminescence
Exclusively available through Celsis, AKuScreen utilizes
the enzyme Adenylate Kinase (AK) to effectively generate
and amplify ATP in the sample. Because the reaction
essentially manufactures ATP, detection occurs sooner
than traditional ATP Bioluminescence with broad spectrum
bacteria detection in as few as 18 hours and mold detection
in 24 hours.
For more information ATP Bioluminescence and AKuScreen technologies, visit our Technical Information page.
Celsis AKuScreen™ Health Brochure
Benefits
Celsis assays are accurate, reliable and easy to use. They yield significant financial benefits in reduced inventory and working capital requirements, reduced manufacturing lead times and improved manufacturing efficiency. In addition, earlier results facilitates an earlier response and correction action when contamination occurs minimizing potential financial impact.
As
most finished product is expected to show no microbial
contamination, Celsis assays
allow for:
- Results in as few as 18 - 24 hours (AKuScreen) or 24 - 48 hours (RapiScreen)
- Reduction in inventory investment and working capital requirements
- Easy opening plastic screw cap vials
- Simplified reagent identification via colour-coded
packaging
- Reduction in lab materials and time needed for
performing tests, allowing a proactive focus on
QA rather than reactive management of QC
- Quicker management response in the occurrence
of contaminated products
- Complete IQ/OQ/PQ documentation and validation
guides
Applications
Celsis has evaluated a range of suitable over-the-counter
pharmaceutical products from different manufacturers
for micro-biological testing using its reagent kits
including, but not limited to:
- Capsules
- Emulsions
- Inhalations
- Pastes
- Suspensions
- Solutions
- Ointments and Tablets
The Celsis Advance™ and Advance
Coupe™
luminometers have been validated and are used by
leading pharmaceutical companies worldwide.
Celsis' Advance.im software is fully compliant
with the requirements of the US food and Drug Administration
(FDA) regulation 21CFR part 11 for testing pharmaceutical
products.
Organisms Detected
Proven on a wide variety of bacteria, yeast and mold
organisms including those resistant to hostile conditions
and/or slow growing organisms.
Validation
Celsis' pharmaceutical product assays were developed
with validation in mind. Celsis offers a comprehensive
validation program with guidelines for IQ, OQ and
PQ. Celsis leadership and experience with implementing
rapid methods has been utilised to develop a straightforward
validation guide for implementing rapid methods in
the pharmaceutical industry. Our experienced team
of microbiologists will guide your company through
the validation process.
