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Sterile Compounding Pharmacy Testing 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, DEA licensed for Schedules II-V, 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 <51> Antimicrobial Effectiveness Testing

  • Suitability of the Recovery Method (Neutralizer Validation)

  • Product Testing per Compendial Product Category

Rapid Sterility Test Using BacT/ALERT®

USP <71> Sterility Test

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

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

Compliance on Demand™ Proficiency Test Kits

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

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