Preservative Efficacy Testing and Suitability Testing for Cosmetic and Toiletry Industries

The cosmetic and toiletry industries employ unique microbiology quality assurance systems that are specifically designed to detect the presence of microbes in cosmetic and personal care products, and deliver accurate and timely results. These microbiology systems perform a variety of typical assays including checking for unpleasant organisms, microbial content like molds and yeast, preservative efficacy testing, and suitability testing.

The Pharmaceutical Industry and Its Dependence on Microbiology

Put simply, microbiology entails the study of microorganisms that one can't see with the naked eye. These are from bacteria, fungi, protozoa and such similar organisms. There is an intricate association between microbes to specific diseases. This has kept scientists at the front on research concerning them for centuries. The role of microbiology on advances within the healthcare industry, and especially the pharmaceutical industry, has led to great discoveries ranging from medicines and vaccines to devices.

Microbiology Quality Assurance and Rapid Microbiological Methods

When it comes to microbiology quality assurance, this is the process whereby the quality of laboratory reports can be guaranteed. Quality control is the part of quality assurance that is mainly concerned with controlling errors when tests are being performed as well as in the verification of the test results. Materials, equipment and procedures have to be controlled adequately. Culture material has to undergo testing for sterility as well as performance. Every laboratory should have Standard Operating Procedures (SOPs). Quality assurances should be incorporated at every stage of a microbiological procedure, which can be done by ensuring that the laboratory is well lit, dust free and air-conditioned. 

Understanding Microbiological Quality Control and Assurance Solutions

In the ever-changing pharmaceutical industry, competition is rife when it comes to the speedy development of products. Microbiological testing is essential to ensure safe products are made without any environmental hazards and at a reduced cost. This has led to an increased use of rapid detection kits that cut costs and time in detection of pathogens in any given sample. 

Regulations and Requirements for Pharmaceutical Microbiology Labs

In microbiology, quality assurance stands for the measures put in place to ensure quality control, as well as quality improvement. Quality control stands for the constant observation of work practices, paraphernalia and chemical substances so as to spot and correct defects. Once there are proper quality control measures in place, then quality improvement comes into focus as a way of making existing systems more efficient.

Everything is New at SupplySide Marketplace 2012!

New venue…new location…Stop by and see what’s new at BioLumix – booth #542 at the SupplySide Marketplace, Javits Center New York City on May 9th & 10th. The BioLumixsystem is the most advanced microbiological testing system of its kind. A demo of theBioLumix system will be available during the tradeshow.

Do you need Validated, Simplified Rapid Microbiology Testing? 

The state-of-the-art BioLumix system helps streamline microbial testing, and allows for easy compliance with cGMP, with over 200 instruments performing assays daily. All of BioLumix customers’ audits by FDA and NSF passed their inspection while using the BioLumix System.

Dealing with difficult to read plates or manual data transfer is a thing of the past. With automated monitoring of ready-to-use assay vials and automated data processing and archiving (paperless), the microbiologist’s job isa lot easier, with the same accurate results inless than half the time.

What is the BioLumix System? 

Test vials areincubated and the assay are monitored every 6 minutes. Each Instrument is capable of simultaneously running 32 test vials at one temperature. The modular structure of the BioLumix System enables flexible growth as needed; up to 1,024 samples can be tested simultaneously with up to 32 instruments connected to a single PC. There is random access to all instrument vial positions at any time. Therefore,no batching is required.

The Biolumix System is designed to accelerate product release with a simplified, automated approach.This yields fast, accurate results while reducing costs. No more waiting days for completed assays. The BioLumix System brings automated microbiological testing in house with most assay results achieved over night, and an Automated Certificate of Analysis within 48 hours for all USP assays. It is simple enough to be operated by no-microbiologists, providing accurate data of raw materials, environmental samples, and finished products.

What would you like to save? Time, money, labor? BioLumix does it all. The BioLumix system is both simple and cost-effective, with its streamlined testing design and single platform testing. The system is designed to accelerate product release using a modified simple methodology. It saves time to results,labor for microbiological testing and money due to its cost effectiveness. In many cases, return oninvestment is takes less than 6 months.

What would you like to test? Tablets, capsules, oils, liquids and powders are easily analyzed andresults are obtained quickly and with real time communication. The simple sample preparation allowstesting for raw materials, in-process product, finished goods, processing water and environmenta ltesting. All of which have been Validated by us, according to USP methodology, so you don’t have to. Infact, we are so excited about our system that we ask your company to send us samples and we will testthem for free so you can see the results!

What Assays would you like to test?

•••••••••

Total Aerobic Microbial Count Total Combined Mold and Yeast Count Enterobacterial Count (Bile-Tolerant Gram Negative Bacteria) ColiformE. coli Pseudomonas aeruginosa Staphylococcus aureus Salmonella Probiotic

Would you like No Product Interference?

The vial design is separated into two zones: the incubation zone where the sample is present, and the detection zone where the readings take place.Therefore, the system prevents any product Interference.

The BioLumix Advantage is:

•••••••••••••

Simplified testing procedures – can be operated by non microbiologists Ready to us vials-shorter sample preparationVial design prevents product interference Real-time communication for immediate action Early warning of contaminated samples An automated Certificate of Analysis within 48 hours including all organisms required by USP Validation package against USP methodology including IQ, OQ and PQ Allows for cost effective internalization of microbiological assays 21 CFR part 11 compliant with audit trail and login/ log out Centralized test data automatically stored and protected Cost reduction of microbiological assays Automation and connectivity – faster product release Allows internalization of microbiological testing
Come See Us at Booth #542!

BioLumix Microbial Limit Vial (MC)

Introduction:

The Microbial Limit vial is used to test primarily Personal Care, Cosmetic and over the counter Pharmaceutical (OTC) products for microbial content (contamination). Each of these types of products may have preservatives in their composition and the Microbial Limit vial helps to neutralize the inhibition of microbial growth that many preservatives provide. Neutralization of the preservative allows for a proper evaluation of whetheror not the product has contaminants. Often the contaminating bacteria in the product while in the presence of the preservative remain “injured” and unable to replicate. Thelack of replication might be interpreted as the lack of contamination.

How It Works

The Microbial Limit vial’s sensor detects production of CO2 by microorganisms, based upon the principle that CO2 is a universal metabolite produced by all microorganisms. The disposable vial contains a transparent solid sensor located at the bottom which changes its optical properties whenever CO2 diffuses into it. Only gases can penetrate the sensor; blocking liquids, microorganisms, and particulate matter. Consequently, the optical readings are not masked by the sample. CO2 generated by bacterial metabolism in the liquid medium diffuses into the sensor and interacts with an indicator reagent to provide an indication of the presence of the carbon dioxide.

Applications:

The Microbial Limit vial is used to test primarily Personal Care, Cosmetic and over the counter Pharmaceutical (OTC) products for microbial content (contamination). Each of these types of products may have preservatives in their composition and the Microbial Limit vial helps to neutralize the inhibition of microbial growth that many preservatives provide. Neutralization of the preservative allows for a proper evaluation of whether or not the product has contaminants. Often the contaminating bacteria in the product while in the presence of the preservative remain “injured” and unable to replicate. The lack of replication might be interpreted as the lack of contamination.

The first step of the assay is to perform a 1:10 dilution of the product in neutralizing broth such as D/E (Dey/Engley) broth, Letheen Broth, or TAT (Tryptone-Azolectin-Tween) Broth. There after 1.0-0.1 ml of the sample is added to the Microbial Limit vial. The Microbial Limit vial contains the neutralizers that inhibit many common preservatives and this neutralization event helps the customer to correctly measure the presence of contaminating organisms.

Examples of Growth Curves Using the Microbial Limit Vial:

In the curves shown below in the Figure, there is an example of both a positive curve and a negative curve. The bacterium used was Pseudomonas aeruginosa.

The BioLumix Microbial Limit vial was specifically designed to be used in complying with USP. Due to the fact the Microbial Limit vial has both Lecithin and Tween in its media composition helps allow for neutralization of the preservative in the sample to be maintained during the assay for viable organisms. Thus, this vial is useful to the customer that has already determined the amount of neutralizing buffer and its content of neutralizer to be used when the product sample is first prepared in diluent. Together the use of the correct neutralizer and the use of the BioLumix Microbial Limit vial helps ensure an accurate assay for the replicating organisms.

Table 1 summarizes the types of Products that customers test in the BioLumix Microbial Limit vial to measure the presence of organisms.

Summary:

The versatility of the BioLumix Microbial Limit vial includes the ability to support growth of most aerobic bacteria, many yeast and some mold organisms. In most cases YMC vial is used for the detection of yeast and molds. The BioLumix Microbial Limit vial can be used for determination of microbial content (contamination), for use in suitability studies that test whether a product can support growth of microorganisms, and in Preservative Efficacy Studies (PET analysis) that is used for cosmetic products. The BioLumix Microbial Limit vial can also be used by customers whose products include Dietary Supplements and Nutraceutical products for which preservatives (natural or chemical) are also added. Supplement products with natural preservatives also need to be neutralized and tested for their ability to support microbial growth.