Pharmacy

 

ARL Bio Pharma provides analytical and microbiological testing for compounding pharmacies, outsourcing facilities, and health-system pharmacies. Our laboratory partners with industry suppliers bringing excellence to the compounding industry.

Submit Samples for testing through ARL's Client Portal. 

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Stability Studies

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).

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Container Closure Testing

The container closure system for a drug product provides critical protection for stability and sterility. ARL offers USP <1207> container closure integrity testing (CCIT) on IV bags, syringes, cassettes, and vials. Three types of leaks that can be detected during CCIT include: 

  1. Entry of microorganisms
  2. Escape of the product dosage form or entry of liquids or solids
  3. Escape of nitrogen gas or entry of oxygen, water vapor, or air gase

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Rapid Sterility

A rapid sterility test detects microbial contamination. This validated alternative sterility test method per USP <1223> is effective and reliable for 503A and 503B Facilities. Rapid test provides objective results in as little as six days.

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Fungal

This test is designed to increase the likelihood of detecting fungal microorganisms in sterile products. 

Microbial Identification

This test identifies microorganisms isolated during different phases of manufacturing and quality testing to the genus/species level using DNA sequencing.

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Antimicrobial Effectiveness Testing USP <51>

Microbiological Examination of Nonsterile Products – Tests for Burkholderia cepacia Complex USP <60>

This test procedure evaluates the microbiological quality, specifically the presence of species of the genus Burkholderia, in non-sterile substances and preparations.  This is important, because Burkholderia is a potentially dangerous pathogen, especially for drugs or raw materials that are intended for inhalation use, and aqueous preparations for oral, oromucosal, cutaneous, or nasal administration. 

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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.

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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.

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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, and Methotrexate

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