|
Microbiological Services |
In July 2002, IAL expanded our facility to accommodate microbiological testing.
Our new laboratory is designed to routinely test many drug and cosmetic raw
materials and products.
Microbiological professionals have been hired to ensure that all operations are
conducted with strict adherence to cGMP protocols. Our staff is trained to understand the
technical requirements as well as our client's need for accurate and timely data.
All microbiological equipment undergoes IQ/OQ/PQ. In addition, to ensure that cGMP
operations are maintained, an environmental control program is implemented that
quickly allows us to detect any adverse drift in microbiological conditions and
allows us to take immediate corrective action. Standard Operating Procedures
identify all sampling frequencies and sites. Alert and action levels are developed
and used as guidelines for our environmental program.
Our services include analysis documented in the United States Pharmacopeia (USP) and
the FDA Bacteriological Analytical Manual (BAM). Many of the products we test require
Microbial Limits and Preservative Effectiveness Testing. If antimicrobial agents are
used in the formulation, IAL can conduct the neutralization of the antimicrobial agent
by one of these techniques: chemical inhibition, dilution or filtration and washing.
The technique utilized depends on the antimicrobial agent in the formulation.
The neutralization of the antimicrobial agent is only required the first time the product is tested for Preservative Effectiveness or Microbial Limits. If the product formulation is changed, the neutralization validation must be repeated.
Our Services Include:
Indicator Organisms
Aerobic Plate Count
Anaerobic Plate Count
Total Coliform Bacteria
Escherichia coli
Gram Negative Bacteria
Yeast and Mold Plate Count
Pathogens
Coagulase Positive Staphylococcus
Pseudomonas aeruginosa
Salmonella
Other organisms can be done upon request of the client and evaluation of the Microbiology Group Leader.
USP Microbiological Testing
Anti-Microbial Preservative Effectiveness
Microbial Limits Testing
Please call our Pharmaceutical and Cosmetic Testing Business Development Department
at 973-361-4252 for more information regarding our microbiological services.
You can also contact us via email at pharminfo@ialonline.com.
|
|
 |
 |
 |
|
