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Home » Services » Pharmaceutical Services

Pharmaceutical Services

ALG is a reliable partner and consultative extension to the cGMP microbiology and testing industry. For 25 years, ALG has partnered with CMOs, CDMOs, hospital and pharmacy compounders, Human Drug Outsourcing Compounding Facilities, biotechnology, cosmetics and health care industries to provide FDA compliance expertise and testing solutions. ALG labs are FDA registered and inspected and ISO/IEC 17025:2017 accredited.

All test labs GLP/cGMP compliant

Testing Services

USP <1072> Disinfection Qualification

  • Coupon testing using immersion recovery method
  • Tube dilution method
  • AOAC use-dilution test
  • Time-kill studies
  • Fungicidal activity tests
  • AOAC germicidal spray products test
  • Use-dilution studies using coupons
  • In-house organisms efficacy studies
  • Custom disinfectant efficacy studies

Biological Indicator Processing and Qualification

Environmental Monitoring

  • Cleanroom EM
    • Sample collection
    • Enumeration and reporting for viable and nonviable particles
    • Trained microbiologists
  • Compressed air/gas sampling
    • Hydrocarbon
    • Water vapor
    • Viable and nonviable particles
  • Cleanroom validation services (IQ/OQ/PQ)
  • Water sampling
    • Purified
    • WFI
  • Swab sampling

USP <61><62> Microbiological Examination of Nonsterile Products

  • Microbial enumeration tests
    • Bioburden determination
    • Total aerobic microbial count (TAMC)
    • Total yeast and mold count (TYMC)
  • Tests for specified microorganisms
  • Method suitability tests
  • Growth promotion testing of media/plates

Rapid Sterility Test Using BacT/ALERT®

USP <71> Sterility Test

  • Method suitability (bacteriostasis and fungistasis testing)
  • Sterility by membrane filtration
  • Sterility by direct inoculation

USP <81> Antibiotic Potency Testing

USP <85> Bacterial Endotoxins Test

  • Gel-Clot Technique
    • Confirmation of labeled lysate sensitivity
    • Non-inhibitory concentration determination (limit test)
    • Test for interfering factors (inhibition/enhancement test)
    • Quantitative product testing
  • Turbidimetric/chromogenic techniques
    • Test for interfering factors (inhibition/enhancement test)
    • Product validation
    • Quantitative product testing

USP <51> Antimicrobial Effectiveness Testing

  • Suitability of the recovery method (neutralizer validation)
  • Product testing per compendial product category

USP <1112> Water Activity Determination for Nonsterile Pharmaceutical Products

USP <55> Biological Indicators-Resistance Performance Tests

  • Total viable spore count (population verification)
  • Identification
  • Purity

USP <1231> Water for Pharmaceutical Purposes

USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments

  • Full service on-site environmental monitoring
  • Incubation and enumeration
  • Growth promotion testing of media/plates
  • Cleanroom validation services (IQ/OQ/PQ)

Microbial Identification

  • TOC
  • Conductivity
  • Bioburden
  • Endotoxin

ISO 14644-1 Classification of Air Cleanliness Certifications

Molecular Cell Biology & Virology Testing

  • Mycoplasma detection
  • Detection of viruses/residual DNA
  • Cytotoxicity
  • Cell line generation
  • Molecular cloning & expression systems
  • Bioproduct safety testing
  • Cell culture services
  • Disinfectant efficacy studies (virus)
  • Molecular-based assays
  • Host cell protein analysis
  • Isoenzyme cell identity assay
  • SDS-Page (R) & SDS-Page (NR)
  • ELISA
  • Immunoblotting
  • Custom studies

Gas Analysis

  • UPS/EP - Nitrogen
  • USP - Medical air
  • USP - Carbon dioxide
  • USP - Oxygen

USP-EU Water Testing

  • TOC
  • USP <791> pH
  • USP conductivity
  • EP Nitrates
  • Endotoxin
  • Bioburden

Nutritional/Food Products

  • Method development
  • Microbial limit test and pathogen screening (USP)
  • Water chemical testing

Cosmetics

Aerobic Plate Count (APC)

Fungi (Yeast and Mold) Plate Count

Anaerobic Plate Count (Use only for Talcs and Powders)

CTFA/PCPC Preservative Efficacy Testing

  • Suitability of the recovery method (neutralizer validation)
  • Product testing

CTFA/PCPC M-1 Determination of the Microbial Content of Cosmetic Products

CTFA/PCPC M-2 Examination for S. aureus, E. coli and P. aeruginosa

USP <1112> Water Activity Determination for Nonsterile Pharmaceutical Products

ALG Compliance Tests

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