Microbiological Services
 
 
 
Microbiological Services

Incorporating broad based technical knowledge of FDA, AOAC, CTFA, USP, and Client Custom Programs, Omega Biological provides unique capabilities. With expertise in the cosmetic and pharmaceutical industries, the Microbiological Department provides not only testing facilities, but consultative capabilities in areas of unusual product or production issues.
 
 
Microbiological Services

Microbial Limit Test USP 31 <61& 62>,AOAC/CTFA(M1 AND M2) and Client Specific Protocols
Pharmaceutical Water Testing :USP/CTFA/AOAC and Client Specific Protocols
Water testing by pour plate method (APHA 9215B, 9215)
Microbial Identification
Method Development and Validation
Minimum Inhibitory Concentration
Total Aerobic Microbial Count
Microbial limit confirmatory tests for Salmonella, Escherichia coli, Staphylococcus aureus & Pseudomonas aeruginosa
Anaerobic Plate Count: Clostridia
APE- Antimicrobial Preservative Effectiveness Testing Or Preservative Effectiveness Testing Or Challenge Test : USP 23 <51> and CTFA(M3 and M4)
Production Equipment Cleaning Validation - Starch granule residue screen
Environmental monitoring - filters, kettles, plates, batch area, filling area etc
Swab test
Air Sampling on site and door to door : Bacterial Count & Fungal Count
Total Coliform (MPN)
 
 
Cosmetics and Personal care products

For the manufacturer of cosmetic and personal care products, it is important to ensure that their products are free of microorganisms and are safe for consumer use. This can only be attained through use of a sound quality assurance and control program. Omega/BioChem, Inc. is a FDA registered highly qualified test laboratory for the cosmetic and personal care industries. Our staff of experienced personnel serves you to assure that your products are free of objectionable microorganisms. Following are the most common tests:


 
 
Aerobic Plate Count (APC):

This test determines the total number of aerobic bacteria in the product. It is a 48 to 72 hour test.
Yeast and Mold Count:
This test determines the total number of yeast and fungi in the product. It is carried out over seven days.
Above both tests requires at least 22gm of the product.
 
Antimicrobial Effectiveness Test (Challenge Test):
Antimicrobial preservatives are added in the products to protect them from microbial contamination. Antimicrobial efficacy test evaluates the effectiveness of an antimicrobial preservative. The microorganism survival is monitored for 28 days. At least 100-150 ml or grams of the product is needed to run this test. The test is carried out in such a way that the product is challenged with the known strains of the microorganisms. Samples are tested at different intervals to determine the survival of the organisms. The test demonstrates the efficacy of the product to stop the growth of organisms such as Staphylococcus aureus, Escherichia coli, Pseudomonas aeriginosa, Candida albicans, and Aspergillus niger.
   
 
Minimum Inhibitory Concentration(MIC):

This test determines the lowest concentration of the product inhibiting visible growth of microorganisms.

 
 
 
 

USP Microbial Limit test:
USP requires preparatory testing to validate the test method that will be used in routine microbial limit testing of the product.

Microbial limit test demonstrates that the product does not inhibit the microorganisms that may be present. Diluted samples of the material are inoculated with separate, diluted cultures of Staphylococcus aureus, Escherichia coli, Salmonella, Candida, and Aspergillus. By means of a challenge of 6 representative microorganisms, preparatory testing demonstrates the ability of the test method to recover microorganisms that could be present on a product.

Microbial limit validation test is required only once per product unless the product formula or manufacturing process has gone through a modification. Turn around time for this test is 7 – 8 days.
Microbial Limit Confirmatory Test:
To confirm the presence or absence of Staphylococcus aureus, Escherichia coli, Pseudomonas aeriginosa, Salmonella , Candida albicans, and Aspergillus niger, microbial identification is performed. It can be tests like coagulase test and oxidase tests or complete microbial identification. Microbial Identification is completed in 2 -4 days.
Dermal/Ocular Irritection Assay (In Vitro):
Evaluation of the sample with the Irritection Assay system in order to predict its potential to cause dermal/ocular irritation. To achieve this objective, we perform a standard weight-dependent dose response study using the Dermal/ocular Irritection test method.
Equipments and Facilities
DI WATER SYSTEM
AUTOCLAVE
MICROPROCESS CONTROLLED WATERBATH
HOT PLATES/STIRRER
LAMINAIRE HOOD
pH METER
UNICO MODELL 2100 SPECTROPHOTOMETER
THERMO CO2 INCUBATOR
INCUBATORS
MOTIC DIGITAL MICROSCOPE
MOTIC MICROSCOPES (B3 PROFSSIONAL SERIES)
VARIETY OF DEHYDRATED MEDIA
BBL CRYSTAL ID KIT
 
 
 
Omega BioChem Laboratories, 56 Park Avenue, Lyndhurst, NJ 07071
(201) 883-1222
© Copyright Omega / Biochem - All Rights Reserved.