Hospitals

ARL Bio Pharma provides analytical and microbiological testing for health-system pharmacies. Our laboratory makes the test process simple so you can meet industry quality requirements and release safe, effective drug products easier and faster.

Submit Samples for testing through ARL's Client Portal. 

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Stability Studies (Beyond Use Dating)

A stability study measures the extent to which a product retains, within specified limits, and throughout its period of storage and use, the same properties and characteristics that it possessed at the time of compounding.

A study commonly includes: a stability indicating method assay, sterility (for sterile preparations), endotoxin (for most sterile preparations), pH, visual inspection, particulate matter, preservative effectiveness, preservative quantification, microbial limits (for non-sterile preparations), and the absence of specified organisms (for non-sterile preparations).

Sterility USP <71>

A sterility test detects microbial contamination. A satisfactory result indicates that no contaminating microorganism has been found in the sample examined under the conditions of the test.

Rapid Sterility

A rapid sterility test detects microbial contamination. This validated alternative sterility test method per USP <1223> is effective and reliable for health-system pharmacies. Rapid test provides objective results in as little as six days.

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Endotoxin USP <85>

An endotoxin test detects toxins that are released from the cell wall of disrupted gram-negative bacteria.

Microbial Identification

This test identifies microorganisms isolated during environmental monitoring and quality testing to the genus/species level using DNA sequencing. 

Environmental Monitoring Plate Testing - Personnel and Surfaces

ARL will incubate client growth media samples at a specified time and temperature.  Once complete, the media will be examined for microbial growth and a CFU count provided to the client on a CoA.

Antimicrobial Effectiveness Testing USP <51>

An antimicrobial effectiveness test demonstrates the effectiveness of antimicrobial preservatives in preventing microbial proliferation in injections, topicals, oral products, single dose vials, and antacids packaged in multiple-dose containers.

Particulate Matter USP <788>/<789>

A particulate matter tests for the presence of extraneous substances including: dust, glass, drug precipitates, rubber and other insoluble materials.

Microbial Disinfectant Cleaning Challenge Studies

Microbial cleaning studies are essential to validating a facility’s cleaning SOP.  Pharmacies must demonstrate that cleaning agents, combined with instructions and procedures for their use, remove microbial contamination from surface areas where sterile drug products are compounded.

USP <800> Surface Wipe Sampling Test

This test measures the level of hazardous drug surface residue to verify workplace safety.

Available drugs:

  • Estriol

  • Estradiol

  • Estrone

  • Testosterone

  • Progesterone

  • Testosterone Propionate

  • Testosterone enanthate

  • Testosterone Cypionate

  • Methotrexate

 

Article: USP800 Why should you test

Drug Diversion Testing

Drug Diversion is the transfer of licit drugs for illicit purposes. ARL Bio Pharma's investigative services can provide additional evidence of drug diversion. Testing services include: drug identity confirmation, unknown drug identification and drug concentration analysis.

All services provided will adhere to ARL Bio Pharma’s terms and conditions