Consumer Product Testing Company Inc.

Our Microbiology Division provides unique capabilities, showcasing expertise across Pharmaceuticals, OTC, Consumer Healthcare, Cosmetic/Personal care, Specialty Chemical and Medical Device Industries. Whether our clients are interested in routine compendial testing or specialized or unique product development, our staff provides technical knowledge associated with the FDA , EPA and International and Client Custom programs. In addition to these trusted programs, our team also offers consultation services for Microbiology issues that may arise.

Our Capabilities

• Microbial Limits / Test Method Suitability
  
  • USP <61>/<62> , EP 2.6.12/EP 2.6.13 and BP, JP, AOAC, ASTM & Client Methods
    
• Antimicrobial Preservative Effectiveness
  
  • USP <51>, PCPC(CTFA), EP 5.1.3, JP, & Client Methods
    
  • ISO 11930
    
• Water Activity Testing (based on USP <1112>)
  
• Water Testing (Qualification and Routine Testing)
  
• Environmental Monitoring (Validations and Routine Monitoring)
  
• Microbial Identifications (Genotypic)
  
• Bioburden (AAMI)
  
• Sterility Validation and Testing (Class 1000 Clean Room)
  
  • USP <71> and AAMI Methodologies
    
• LAL/Endotoxin Testing, USP <85>
  
• Antibiotic Potency Assays, USP <81> – Routine Testing and Method Verification
  
• Stability Testing Programs – ICH Guidelines
  
• Disinfectant and Antiseptic Efficacy USP <1072>
  
• Antimicrobial Studies (In-Vitro and In-Vivo)
  
• Ames Mutagenicity Testing (OECD 471, ISO)
  
• FDA BAM Chapter 23 – Cosmetic Testing / Import Detentions
  
• Custom Research Projects/Client Specific Protocols
  
• Regulatory Consulting
  
• Specialty Programs
  
  • Antiseptic Efficacy Studies
    
• Informational References
  
  • US Food and Drug Administration (FDA)
    
    • Microbiological Safety and Cosmetics
      
    • FDA Pharmaceutical Microbiology Manual
      
  • United States Pharmacopeia (USP)
    
    • USP General Chapter <61>—Microbial Examination of Nonsterile Products: Microbial Enumeration Tests
      
    • USP General Chapter <62>—Microbial Examination of Nonsterile Products: Test for Specified Organisms
      
    • USP General Chapter <51>—Antimicrobial Effectiveness Test
      
    • ISO 11930 Cosmetics — Microbiology — Evaluation of the antimicrobial protection of a cosmetic product
      

• FDA/ICH Stability Programs
  
• Freeze-Thaw
  
• Cosmetic Stability
  
• Light Stability
  
• Period After Opening (PAO)

• Prescription Pharmaceuticals
  
• OTC Pharmaceuticals
  
• Sunscreens
  
• Antibacterials
  
• Custom Assay / Method Development

• USP / Ph. Eur. / BP / JP Compendial Testing
  
• Wet Chemistry
  
• Raw Material Vendor Qualification Programs

USP <61>/<62> , EP 2.6.12/EP 2.6.13 and BP, JP, AOAC, ASTM & Client Methods

Before a new medical device enters the market, it must meet an extensive list of requirements and standards. Therapeutic quality testing is imperative for our clients and also the general public.

If you plan on bringing pharmaceutical, OTC, medical device or nutritional products to the marketplace, CPT can provide guidance to help navigate the regulatory and compendial guidelines. From raw materials, assays, stability and finished products to IND, NDA and ANDA submissions, CPT can assist with your analytical testing requirements.
CPT can assist personal care companies with testing, such as, low level detection and claims, preservatives and formula stability.

Our Capabilities

Raw Material Analysis
USP / Ph. Eur. / BP / JP Compendial Testing
Wet Chemistry
Raw Material Vendor Qualification Programs
Pharmaceutical Water Testing
Full Monograph Testing
Systems Validation and Qualification
Methods Development & Validation Expertise
Prescription Pharmaceuticals
OTC Pharmaceuticals
Sunscreens
Antibacterials
Custom Assay / Method Development
Low Level Detection and Claims
Parabens Testing for “Parabens Free” claims
Gluten Testing for “Gluten Free” claims
Heavy Metals Testing
Extractables and Leachables (e.g. Phthalates)
Preservatives, Antiseptic Products Testing
Preservatives Testing
Alcohol Testing
Antiseptic Active Ingredients Testing
Systems Validation Programs
Process Validation
Cleaning Validation
Stability Shelf-Life Testing
FDA/ICH Stability Programs
Freeze-Thaw
Cosmetic Stability
Light Stability
Period After Opening (PAO)
Batch Release
USP Container Testing
Capabilities/Equipment
UPLC and UPLC/MS
HPLC and HPLC/MS
GC and GC/MS
ICP/MS
IC
Dissolution
DSC
FTIR
AA
UV
TLC
Titrations
Wet Chemistry
Controlled Substances (DEA Class I-V license)

Before a new nutritional product (therapeutic product) enters the market, it must meet an extensive list of requirements and standards. Therapeutic quality testing is imperative for our clients and also the general public.

If you plan on bringing pharmaceutical, OTC, medical device or nutritional products to the marketplace, CPT can provide guidance to help navigate the regulatory and compendial guidelines. From raw materials, assays, stability and finished products to IND, NDA and ANDA submissions, CPT can assist with your analytical testing requirements.
CPT can assist personal care companies with testing, such as, low level detection and claims, preservatives and formula stability.

Our Capabilities

Raw Material Analysis
USP / Ph. Eur. / BP / JP Compendial Testing
Wet Chemistry
Raw Material Vendor Qualification Programs
Pharmaceutical Water Testing
Full Monograph Testing
Systems Validation and Qualification
Methods Development & Validation Expertise
Prescription Pharmaceuticals
OTC Pharmaceuticals
Sunscreens
Antibacterials
Custom Assay / Method Development
Low Level Detection and Claims
Parabens Testing for “Parabens Free” claims
Gluten Testing for “Gluten Free” claims
Heavy Metals Testing
Extractables and Leachables (e.g. Phthalates)
Preservatives, Antiseptic Products Testing
Preservatives Testing
Alcohol Testing
Antiseptic Active Ingredients Testing
Systems Validation Programs
Process Validation
Cleaning Validation
Stability Shelf-Life Testing
FDA/ICH Stability Programs
Freeze-Thaw
Cosmetic Stability
Light Stability
Period After Opening (PAO)
Batch Release
USP Container Testing
Capabilities/Equipment
UPLC and UPLC/MS
HPLC and HPLC/MS
GC and GC/MS
ICP/MS
IC
Dissolution
DSC
FTIR
AA
UV
TLC
Titrations
Wet Chemistry
Controlled Substances (DEA Class I-V license)

Being global industry leaders in sun protection testing for more than 25 years, our Photobiology Division offers services utilizing methods adopted worldwide for compliance to regulatory requirements. In addition to standard SPF, PFA, Phototoxicity and Photoallergy testing, CPT works with our clients to determine novel testing methods including sand resistance, water protection, and pilot research programs.

Our Capabilities

• PHOTOTOXICOLOGY
  
  • Photoallergy (6 week test)
    
  • Phototoxicity (4 day test)
    
• SUNSCREEN EFFICACY TESTING
  
• SPF Protection Efficacy
  
  • FDA Final Rule (2011)
    
  • Cosmetics Europe (COLIPA)
    
  • ISO 24444
    
• 40 and 80 minute Water Resistant Testing
  
  • FDA Final Rule (2011)
    
  • Cosmetics Europe (COLIPA)
    
• UVA Protection Efficacy (UVAPF)
  
  • JCIA (PPD – Persistent Pigment Darkening Method)
    
  • ISO 24442
    
• CLAIM SUBSTANTIATION
  
  • Sand Resistance
    
  • Rub off Potential
    
  • In-Vitro
    
    • FDA Broad Spectrum
      
    • ISO 24443
      
• Custom Protocol Development to meet your needs
  
  • GMP sunscreen Assays (all organic and inorganic actives, including TiO2 and ZnO), Raw Material testing, Method Validation, Process Validation and Stability Services also available.
    
  • GMP Consulting by in-house experts, including, Compliance Audits and Vendor Certification Programs.
    

Before a new pharmaceutical, OTC, medical device or nutritional product (therapeutic products) enters the market, it must meet an extensive list of requirements and standards. Therapeutic quality testing is imperative for our clients and also the general public.

If you plan on bringing pharmaceutical, OTC, medical device or nutritional products to the marketplace, CPT can provide guidance to help navigate the regulatory and compendial guidelines. From raw materials, assays, stability and finished products to IND, NDA and ANDA submissions, CPT can assist with your analytical testing requirements.
CPT can assist personal care companies with testing, such as, low level detection and claims, preservatives and formula stability.

Our Capabilities

• Raw Material Analysis
  
  • USP / Ph. Eur. / BP / JP Compendial Testing
    
  • Wet Chemistry
    
  • Raw Material Vendor Qualification Programs
    
• Pharmaceutical Water Testing
  
  • Full Monograph Testing
    
  • Systems Validation and Qualification
    
• Methods Development & Validation Expertise
  
  • Prescription Pharmaceuticals
    
  • OTC Pharmaceuticals
    
  • Sunscreens
    
  • Antibacterials
    
  • Custom Assay / Method Development
    
• Low Level Detection and Claims
  
  • Parabens Testing for “Parabens Free” claims
    
  • Gluten Testing for “Gluten Free” claims
    
  • Heavy Metals Testing
    
  • Extractables and Leachables (e.g. Phthalates)
    
• Preservatives, Antiseptic Products Testing
  
  • Preservatives Testing
    
  • Alcohol Testing
    
  • Antiseptic Active Ingredients Testing
    
• Systems Validation Programs
  
  • Process Validation
    
  • Cleaning Validation
    
• Stability Shelf-Life Testing
  
  • FDA/ICH Stability Programs
    
  • Freeze-Thaw
    
  • Cosmetic Stability
    
  • Light Stability
    
  • Period After Opening (PAO)
    
• Batch Release
  
• USP Container Testing
  
• Capabilities/Equipment
  
  • UPLC and UPLC/MS
    
  • HPLC and HPLC/MS
    
  • GC and GC/MS
    
  • ICP/MS
    
  • IC
    
  • Dissolution
    
  • DSC
    
  • FTIR
    
  • AA
    
  • UV
    
  • TLC
    
  • Titrations
    
  • Wet Chemistry
    
• Controlled Substances (DEA Class I-V license)