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Home » Services » Pharmaceutical Services » Sterile Compounding Pharmacy Services

Sterile Compounding Pharmacy Services

ALG provides USP <797>, USP <800> and cGMP FDA compliance expertise and testing solutions for home infusion, pharmacies, hospital pharmacies and human drug outsourcing compounding facilities. ALG labs are FDA registered and inspected and ISO/IEC 17025:2017 accredited.

All test labs GLP/cGMP compliant

Pharmacies, Hospitals, Infusion and Sterile Compounding Facilities

USP <797> Pharmaceutical Compounding-Sterile Preparation

  • Environmental monitoring program implementation
  • Full service on-site environmental monitoring
  • Incubation and enumeration/genus ID for environmental monitoring samples
  • Growth promotion testing of media/plates
  • Cleanroom validation services (IQ/OQ/PQ)
  • ISO 14644-1 Classification of air cleanliness certifications
  • Air flow visualization (AFV)
  • Cleanroom cleaning and disinfection program implementation
  • USP <1072> disinfection qualification
  • Compliance gap analysis
  • Staff training
    • Staff media fill, gowning and gloving proficiency testing
    • Educational programs

USP <800> Hazardous Drugs-Handling in Healthcare Settings

  • Consultation
  • Compliance gap analysis
  • USP <71> Sterility Test

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

    Rapid Sterility Testing Using BacT/ALERT®

    Endotoxin Testing by LAL Method

    • Kinetic Turbidimetric
    • Kinetic Chromogenic
    • Gel Clot

    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

    cGMP Consulting

    USP <1072> Disinfection Qualification

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

    USP <1207> Sterile Product Packaging-Integrity Evaluation

    USP <1231> Water for Pharmaceutical Purposes, Water System Validation (IQ, OQ, PQ)

    ISO 14644-1 Classification of Air Cleanliness

    ANSI/AAMI/ISO 11135/11137-Sterilization of Health Care Products

    Compressed Air/Gas Testing

    Media Fill

    Education / Training

    Aseptic Processing

    Aseptic Water Sampling

    Cleanroom Basics

    Environmental Monitoring

    Pharmaceutical Water Systems

    cGMP

    USP <797> Sterile Compounding

    USP <800> Hazardous Drugs-Handling in Healthcare Settings

    Cleaning and Disinfection

     

    ALG Compliance Tests

    Listings by Qualifying Agency:

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