Pharmaceutical Testing

RX Testing

ATL grew its business serving pharmaceutical companies. Helping drug production facilities with product sterility, quality water testing and environmental monitoring remains at the core of our business.

Our standard services are below, but if you need a procedure you don’t see here, please contact us and we can likely provide it. Biological indicators and endotoxin testing are procedures we will be bringing on board as demand grows.

Have a question or ready to place a test order?


Call Devona at 410-980-9833 or visit our

CONTACT PAGE

SERVICES

Microbial Identification
  • Bacteria, yeast and filamentous fungi
  • Bacterial identification reports are sent after 5-7 business days, fungal and yeast identifications may take longer.
USP <62> Testing for Specific Organisms
  • Salmonella, Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus.
USP <61> Microbial Enumeration Tests
  • USP <61> quantifies TAMC (total aerobic microbial growth) by plating serial dilutions on nutrient agar and incubating for 3-5 days at 30-35C. Bacterial and fungal colonies are recovered and reported as CFU/mL.
  • USP <61> also quantifies TYMC (total yeast and mold) by plating serial dilutions on media specific for fungal growth for 5-7 days at 20-25C.
USP <1231> Bioburden Analysis / Water Testing
  • USP <1231> includes purified water, Ro-di (Reverse-Osmosis deionized) water, WFI (water for injection) or any water for pharmaceutical use. Samples are run through a pump and plated on TSA (tryptic soy agar) and SDA (sabouraud Dextrose Agar). TSA incubates for 2-5 days at 30-35C and SDA incubates at 20-25C for 5-7 days. Bacterial, yeast, and fungal colonies are numerated are reported as CFU/mL (colony forming units/mL).
  • We require a minimum amount of 700mL.
USP <645> Conductivity Three Stage Testing
  • Conductivity testing is a measure of the ion-facilitated electron flow. Conductivity can be affected by gases, extraneous ions dissociated water molecules. Conductivity is reported as a PASS/FAIL test based on the acceptance criteria stated in the USP guidelines.
USP <797> Sterile Preparations for Compounding
  • USP <797> controls the compounding and administration of pharmaceutical products, with the goal of protecting patients from any adverse effects from the contamination of compounded sterile preparations.  
USP <791> pH Testing
  • We can test the pH of solids or liquids.
USP <800> Hazardous Drug Handling
  • In addition to environmental monitoring, our testing includes cleaning effectiveness, personal hygiene, gowning procedures and comprehensive hazardous drug residue sampling. 

FAQ

When will I receive results?

Different incubation parameters will determine when results are available. Rush samples can be requested.

Is your media qualified?

We purchase our media from certified vendors that come with certifications of analysis. Every shipment we receive is under quarantine until released from our growth promotion and sterility testing.

Recommended shipping procedures?

Any sample receiving microbial contamination analysis will need to be shipped cold, unless previously discussed. The temperature will be taken upon arrival and the sample will go through a test inspection per our receiving inspection procedure. If we notice any non-conforming samples, we will immediately notify you and decide if we need new samples or continue with the testing.

Is your equipment properly sterilized?

Any materials we use that requires sterilization is autoclaved.

X