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Photobiology Services

CPTC has been at the forefront of sun protection testing ever since the Photobiology Department was created more than 25 years ago. CPTC is an active member of the PCPC Sunscreen Task Force collaborating in the PCPC and Cosmetics Europe (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 phototoxicity 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 36 solar simulators (27 single-port and 9 multi-port.) Solar simulators are calibrated regularly by Dr. Robert Sayre, the top radiometry expert, and regularly calibrated and monitored by CPTC’s Metrology Department. Three hot tub/whirlpools are set for different regulatory requirements for water resistance testing.

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 testing. A 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 methods, all water resistant methods, and all UVA protection methods, CPTC also offers novel tests such as sand resistance and in vitro analysis of sunscreen formulations. CPTC has significant experience with all types of sunscreen formulations, analyzing for sunscreen actives, conducting method validation studies and developing stability programs to meet FDA GMPs, ISO, and ICH guidelines.

All personnel in CPTC's Photobiology Department are fully trained in CPTC Standard Operating Procedures, current Good Clinical Practices, FDA, ISO and and International test methodology. CPTC's Quality Assurance Unit reviews all studies for protocol and regulatory compliance to ensure that they have been conducted in accordance with ICH Guideline E6 for Good Clinical Practice, 21 CFR Parts 50 and 56, the Declaration of Helsinki (as amended), CPTC Standard Operating Procedures, and other federal and state applicable laws and regulations. The leadership role maintained by CPTC over a long history provides our clients with expertise whether choosing standard testing or collaboration in a novel protocol.

Capabilities

  • PHOTOTOXICOLOGY
    • Photoallergy (6 week test)
    • Phototoxicity (72 hr test)

  • SUNSCREEN EFFICACY TESTING
    • SPF Protection Efficacy
      • FDA Final Rule (2011)
      • Cosmetics Europe (COLIPA)
      • ISO 24444
    • Water Resistant / Very Water Resistant (SPF/PFA)
      • FDA Final Rule (2011)
      • Cosmetics Europe (COLIPA)
    • UVA Protection Efficacy (PFA)
      • JCIA (PPD - Persistent Pigment Darkening Method)
      • ISO 24442

  • CLAIM SUBSTANTIATION
    • Sand Resistance
    • Rub off Potential
    • In-Vitro
      • SPF
      • UVA
      • Critical Wavelength (Boots Star, Diffey, COLIPA)
      • FDA Broad Spectrum
      • ISO 24443


  • Custom Protocol Development to meet your needs

  • GMP sunscreen Assays, Validation and Stability Services also available