Primary Methods Performed
A wide range of methods are used to test both raw
materials and finished products in accordance with
compendial procedures including but not limited to:USP/NF,
BP, EP, JP, AOAC, FDA-BAM, ASTM, AAMI and In-house
and client supplied methods
Analytical
Services
Analyses are performed in compliance with cGMP
requirements. GLP testing is available at the client's
request.
- Antibiotic Assays
- Sterility Testing
- Microbial Limits
- Bioburden Analysis
- Celsis Rapid Screening Services
- Stability Storage and Testing
- Microscopic Procedures
- Water Testing
- Microbial Identification
- Antiseptic and Disinfectant Evaluations
- Preservative
Effectiveness Testing
- Vitamins and Amino Acids
- Bacterial Endotoxin Test
- Ames Mutagenicity
- Methods Development and Validation
- in vitro Assays
- Enzyme Assays
- Fungal Resistance Tests
- Particulate Matter Testing
- Particle Size Distribution
Testing
- Microbial Ingress Tests
- Special Projects
- Heparin and Protomine Testing
- Cytotoxicity Testing
- Determination of Minimum Inhibitory Concentration
Testing
- Minimum Lethal Concentration
Project Partnerships
In addition, we provide method development
support for those projects that require additional
protocol elaboration and project stewardship, such
as:
- Rapid Method Evaluation - We
are the first laboratory to offer Celsis Rapid Screening
and validation services. We will help you develop
and complete a validation protocol for raw materials,
finished products, or process water.
- Antimicrobial Evaluation - We
have provided claim substantiation for formulators
of many antimicrobial products. In addition to EPA
GLP registration of sanitizers and disinfectants,
we have tested a variety of unique antimicrobial
matrices, including plastics, sponges, textiles,
soaps, and lotions.
- Environmental Monitoring - We
can assist in the collection and identification
of air and surface contaminants in your manufacturing
environment. These organisms can be stored for future
use in product challenge studies.
Facilities and
Equipment
- Two Class 100 Clean Rooms
- Vitek 60 Microbial ID System
- Particle Counters: HIAC/Royco and Shimadzu
- MIDI Identification System
- Celsis Rapid Microbial Risk Management Products
