Microbiology

Rapid Sterility

Purpose - Check for microbial contamination in half the time with ATP-bioluminescence! Validated alternative method per USP <1223> and compliant with <797> <71> if the required number of vials are provided based upon the batch size, and if Rapid Sterility Method Suitability has been completed.

Sample Required - Refer to USP <71> Table 3 for batch size information

Turn Around - Results are available within 7 days*

_{* Requires 6 calendar days for incubation. Can integrate into Sterility (14 day) test with advance notice (+$130).}

Rapid Sterility Method Suitability

Purpose - To validate the method used during Rapid Sterility testing will recover microbial contamination if present in routine samples. Not compatible with previous Sterility Method Suitability (14 day). USP <71>.

Sample Required - 3 x the required USP batch size*

Turn Around - Results available within 7 days.

_{* Please refer to USP <71> Table 3 for batch size information, or call us and for guidance.}

Sterility

Purpose - Checks for microbial contamination. Satisfies USP <797> and <71> compliant if the required number of vials are provided based upon the batch size, and if Sterility Method Suitability has been completed.

Sample Required - Refer to USP <71> Table 3 for batch size information

Turn Around - Results are available within 14 days with preliminary result at 7 days

Sterility Method Suitability

Purpose - To validate the method used during Sterility testing will recover microbial contamination if present in routine samples. USP <71>.

Sample Required - 3 x the required USP batch size*

Turn Around - Results available within 14 days

_{* Please refer to USP <71> Table 3 for batch size information, or call us and for guidance.}

Endotoxin

Purpose - This test determines the levels of endotoxins from Gram-negative bacteria using amoebocyte lysate from the horseshoe crab. USP <85>.

Sample Required - 1 container (2 mL minimum)

Turn Around - Results available within 3 business days

Fungi

Purpose - Check specifically for presence of fungal contamination. This test provides a more favorable media for molds and yeast. USP <71>.

Sample Required - 1 container

Turn Around - Results available within 14 days

Antimicrobial Effectiveness

Purpose - This test assesses the effectiveness of the antimicrobial agent(s) in a formulation when challenged by specific microorganisms (Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Candida Albicans, Aspergillus brasiliensis). Required for aqueous formulations, per <795>, or multi-dose formulations, per <797>. USP <51>.

Sample Required - Minimum 55 mL

Turn Around - Results available within 40 days*

_{* Requires 35 calendar day incubation.}

Water Activity

Purpose - Test for the presence of water vapor which can support microbial growth and contribute to the hydrolytic breakdown of active ingredients. Used to classify formulation as aqueous (≥0.6 aW) or non-aqueous (<0.6 aw), per <795>. USP <922>. 

Sample Required - Minimum 5 mL or 5 g

Turn Around - Results available within 7 business days

Microbial Enumeration of Nonsterile Product

Purpose - Also known as "Bioburden" testing, this test determines the total viable aerobic microbial count present in a product. USP <61>.

Sample Required - A minimum of 10 mL or 10 g

Turn Around - Results available within 7 business days

Test for Specified Microorganism in Nonsterile Product

Purpose - Checks for the presence of E. coli, Salmonella, Staphylcoccus, or Pseudomonas in a product. USP <62>

Sample Required - 10 mL* of 10 g*

Turn Around - Results available within 7 business days

_{* Requires 2 x sample amount for validation.}

Subvisible Particulates

Purpose - Determines the number of subvisible particles in parenterals (USP <788>) and ophthalmic (USP <789>¹) solutions in specified ranges: ≥10µm, ≥25µm, ≥50µm¹. The amount of sample to be tested should be be statistically representative of the total lot / batch. 

Method 1 - Light Obscuration and Validation
Method 2* - Microscopic

Sample Required - Minimum of 25 mL

Turn Around - Results available within 7 business days

_{* Requires performing Method 1 first.}