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January 30, 2013

Pharmaceutical Stability Testing

Filed under: Uncategorized — Tags: — mjk @ 6:08 pm

Kappa Laboratories performs stability testing protocol for pharmaceutical products under FDA regulations. Stability is defined as the extent to which the product retains the same properties and characteristics that it possessed at the time of its manufacture. Chemical. Physical, Microbiological, Therapeutical and Toxicological. Test for determination of idenity, purity, and quality would be outlined prior to stability study. Contact us for more information.

March 8, 2012

Export Health Certificate

Filed under: Uncategorized — Tags: — mjk @ 8:49 pm

Kappa Laboratories performs full documentation and summary of reports. We Notarize the Export Health Certificate to countries worldwide. 25 years of Claim Analyses Experience. The Laboratory of Choice for Major Export and International Firms.Chemical Analysis includes – Product Fingerprinting – Scromboid Toxins in Seafood – Indole and Toxins Decomposition Markers – Salmonella – Listeria – E. coli – mold / Yeast – Cosmetic – Pharmaceutical – Nutritional and Eviornmental areas.

February 17, 2012

Legal Analyses

Filed under: Uncategorized — mjk @ 5:03 pm

Kappa Laboratories is frequently contacted by Legal Firms concerning Contaminated Food or Water, Extraneous Material or Unidentified Material as well as Patent and Underwriter testing.  The determination of a harmful substance or contamination which may render as artical not fit for human consumption begins with initial contact and maintenance of the Sample condition and Custody.  From specific case information supplied, the condition of this material to be identified must be preserved durning handling with all steps under Chain of Custody.

January 4, 2012

Kappa Laboratories SHELF LIFE TESTING

Filed under: Uncategorized — mjk @ 6:45 pm

State of Florida Department of Health Certified at both laboratory locations.

 

DOH #E86942

 

SHELF LIFE TESTING

 

Shelf life testing is performed to test the bacterial integrity of a finished product. Demonstrating the absence of pathogenic bacteria in the product is the safest way of avoiding consumer cases regarding food borne illness. The finished report is an excellent sales tool as it indicates that the product is shelf stable and free of pathogenic bacteria.

 

Refrigerated Shelf Life Study:

 

An initial sample is tested for the following Microbiological Series when the samples are received.  After being tested, the sample is returned to the Chemistry laboratory and the pH is measured.   The remaining three samples are placed under refrigeration at 40 Degrees Fahrenheit until the time they are to be tested.  The time points for the testing in a refrigerated study are determined by the nature of the product.  The following tests will be performed according to the AOAC methods cited below.

 

Analyses performed:

Total Aerobic Count (Aerobic Plate Count): FDA Bacteriological Analytical Manual (BAM), 8th Edition, Chapter 3, 1998.

 

Coliform Count & E.coli: AOAC, 17th Edition Chapter 17, Section 966.23 – 966.24. FDA Bacteriological Analytical Manual (BAM), 8th Edition, Chapter 4, 1998.

 

Staphylococcus aureus: AOAC, 17th Edition Chapter 17, Section 975.55 & 987.09. FDA Bacteriological Analytical Manual (BAM), 8th Edition, Chapter 12, 1998

 

Total Molds and Yeast (Aerobic Plate Count) FDA Bacteriological Analytical Manual (BAM), 8th Edition, Chapter 18, 1998.

 

Salmonella sp.: AOAC, 17th Edition, Chapter 17, Section 967.25 – 967.27, 999.09, 978.24 and 989.13, 995.20

 Time Points to be examined:

 A projected Shelf Life should include a reasonable time for production, Distribution,Saleand Consumption.  Also, the Shelf Life should be established beyond the actual expiry date to insure that an out of date product is safe beyond the expiry date marked.  A projected expiry date of fourteen (14) days should have a final time point at 18 to 21 days.  The data will then provide a margin of documented Product Safety.  Time Points would be Initial, Day 7, Day 14 and Day 21.  If products need to have preservatives in order to meet these requirements, the laboratory will assist in finding a supplier of Food Grade Preservatives and will guide in the implementation of these into the product in co-ordination with the supplier to insure accuracy and effectiveness.

     The general approach to avoiding consumer cases regarding food borne illness is to run a Microbiological Series of tests consisting of the following: 

     Total Plate Count    -   All of the Aerobic Bacteria present.  This test gives a general view as       

                                       to the Microbiological condition of the sample.

    Coliforms                -    Coliform bacteria are indications of general sanitation status of             

                                        the product.

    E. coli                     -    E. coli is a human fecal marker and should not be present.  May                                                      represent a pathogen.

    Staph. aureus        -    Staphylococcus aureus is a common cause of food poisoning derived                                           from product handling.

    Mold /Yeast             -   Can be spoilage organisms and can produce aflatoxins.  Some                                                       individuals have allergic reactions to both mold and yeast.

    Salmonella              -   Human Pathogen – no tolerance

    Listeria sp.              -   Human Pathogen – Listeria monocytogenes – no tolerance.

 Upon the completion of the study a report is issued containing the four sets of test results indicating the testing time points. The results will indicate the stability of the product and the report will contain the following statement:

 Based upon the Microbiological results of the sample listed above and insofar as the analyses performed were able to assay for the presence or absence of specific pathogens, the product represented by the sample analyzed would appear to be wholesome and fit for human consumption for a projected 1year (2 years)

 Refrigerated Shelf Life Testing, which is performed in real time, is also available.

                                                                                

*Requires five (5) finished product samples to be submitted per product per study.

 Kappa Laboratories has been Inspected and previously Recognized by the U.S. Department of Agriculture (USDA Microbiology-#0093, Chemistry-#1282); EPA-NELAC Certified by the Florida Dept. of Health, Drinking Water including Microbiology, Pesticides; Environmental Certification as Basic Environmental Laboratory (DOH #E86942); Registered with the U.S. Food and Drug Administration (FDA-#1039389) and is an FDA Accepted Laboratory for Import Testing.  Kappa Laboratories is currently a Contract Laboratory to the U.S. Centers for Disease Control (CDC), Atlanta, Georgia; Vessel Sanitation Program.  ContractLaboratory,U.S.Coast Guard for Alaskan Vessel Discharge Program.

December 15, 2011

Microbiological Analyses – Fit For Human Consumption

Filed under: Uncategorized — mjk @ 4:50 pm

The Total Plate Count is a general indicator of the total amount os aerobic bacteria present. As the Total Aerobic bacterial count increases beyond several hundred thousands of counts.  Decomposition develops rapidly as bacterial growth enters logarithmic phase. This Decomposition is apparent by Off-Odor.  Coliforms and Gram Negative bacterial organisms which are indicators of Sanitation and food product handling.  Coliforms are found in nature and man as well as animals. Fecal Coliforms are mammalian in nature either from man or a mammal.  E. coli is considered a human fecal Coliform marker and this being present in a ready to eat food product is a problem and is a HACCP ( Hazard Analysis Critical Control Point ) regarded organism.  E. coli should not be detected in normal fresh wholesome non-meat products.  Hands – feces – hand product contact is the primary vector suspected when E. coli is present in a finished Ready to Eat or Seafood product.  There is no Regulatory tolerence for Salmmonella/25 grams and Listeria/25grams.  The State of Florida considers Listeria Monocytogenes to be a Human Pathogen but the USDA considers and Listeria presence to be not acceptable.  Production plant remediation of Listeria may be a difficult process and should be understood in order to eradicate and control this bacteria.  Mold and Yeast are spoilage organisms and if Mold growth is present inthe Vegetative state as visible Mold this is considered a form of Decomposition  These series of Microbiological test are used to assess the overall quality and projected shelf-life of a food product

 

 


Main Laboratory
2577 NW 74th Ave.
Miami, Florida 33122

Mt. Sinai Medical Center
Biomedical Research
4300 Alton Road
Miami Beach, Florida 33140

Phone: (305) 599-0199
Fax: (305) 592-1224
Email: info@kappalabs.com

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