Photobiology Services
CPTC has been at the forefront of ultraviolet radiation testing ever since the Photobiology Department was created more than 20 years ago. CPTC is an active member of the PCPC Sunscreen Task Force collaborating in the CTFA and Colipa Round Robin tests used to establish testing standards. Today, CPTC continues their leadership role in developing new clinical assays for sunscreen performance, in analyzing test materials for phototoxicty and photoallergy, and in contributing to basic research.
CPTC maintains single and multi-port solar simulators to meet regulatory and scientific requirements of UV protection testing. Our testing laboratory houses 17 single and 10 multi-port solar simulators. We maintain three hot tub/whirlpools, which are calibrated to different regulatory requirements. Each solar simulator is calibrated annually by the top radiometry expert, Dr. Robert Sayre, and frequently calibrated by CPTC’s Metrology Department.
The large bank of solar simulators allows CPTC to conduct photoallergy tests and phototoxicity tests on new formulations and on new chemical entities while continuing sunscreen efficacy testingA large population of more than 50,000 potential subjects allows CPTC flexibility and diversity in the subject population available for testing.
While CPTC offers all standard SPF tests, all water resistant and very water resistant tests, and all UVA protection tests, CPTC also offers novel tests such as SPF sand resistance and in vitro analysis of sunscreen formulations. Sunscreen formulations can also be analyzed for levels of active ingredients by our Analytical Services Department. CPTC has significant experience with all types of sunscreen formulations, conducting Method Validation studies and Stability programs to meet FDA and ICH guidelines.
All personnel from our Principal Investigator to our Clinical Research Associates are fully trained in CPTC Standard Operating Procedures, Good Clinical Practices, FDA Monograph test methods, and International test methods. Our Quality Assurance Unit reviews all studies for compliance with study requirements to ensure that it has been conducted in accordance with ICH Guideline E6 for Good Clinical Practice, the requirements of 21 CFR Parts 50 and 56, other applicable regulations, CPTC Standard Operating Procedures, and the approved Study Protocol. Maintaining a leadership role during our long history provides our clients with expertise whether they choose standard testing, or require the collaboration and generation of a novel protocol.
Capabilities
- PHOTOTOXICOLOGY
- Photoallergy (6 week test)
- Phototoxicity (72 hr test)
- SUNSCREEN EFFICACY TESTING
- UVB Protection Efficacy (SPF)
- FDA Final Monograph
- Proposed Amendment to the Final Monograph
- International
- Australian/New Zealand
- Water Resistant / Very Water Resistant (SPF/PFA)
- FDA Final Monograph
- Proposed Amendment to the Final Monograph
- Colipa
- Australian/New Zealand
- UVA Protection Efficacy (PFA)
- PPD (Persistent Pigment Darkening Method) (JCIA)
- Proposed Amendment to the Final Monograph
- CLAIM SUBSTANTIATION
- Sand Resistant
- Sweat Resistance/Rub off Potential
- In-Vitro
- SPF
- UVA
- Critical Wavelength (Boots Star, Diffey)
- Proposed Amendment to the Final Monograph
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Determination of the Labeled (PDP) UVA Protection Value - Proposed Amendment to the Final Monograph
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Custom Protocol Development to meet your needs
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GMP sunscreen Assays, Validation and Stability Services also available
