Industry Primer | Products | Calculations | Test Program Setup | Additional Resources
For a quick introduction of LuminUltra's capabilities in this market, go here.
Background
The life science industry covers a broad range of products – most of which use significant amounts of water. Product such as pharmaceuticals, medical devices, vitamins, and personal care products all rely heavily on water, and as such, require rigorous quality control programs to ensure adequately clean water is used. In many cases, water quality standards in the life science industry are understandably very stringent (e.g. USP) and therefore require highly sensitive quality control protocols.
While many of these situations are beyond the limits of ATP technology, there are many opportunities where on-the-spot feedback provided by ATP monitoring can be an invaluable asset. Personal care products, specifically, are intended for therapeutic and hygiene needs unlike many pharmaceutical products that are ingested. They include things like shampoos, hand creams, lotions, toothpaste, and sunscreen. Due to the diversity of these products and the fact that they are extensively used world-wide, it encompasses an enormous market. While similar to health care products, they are more therapeutic rather than medicinal, and for that reason, they are usually subject to the same regulatory boards such as the following
- United States Pharmacopeia (USP): http://www.usp.org/
- Food & Drugs Act (Canada): http://www.hc-sc.gc.ca/fn-an/legislation/acts-lois/act-loi_reg-eng.php
- FDA Cosmetics Q&A (USA): http://www.fda.gov/Cosmetics/ResourcesForYou/Consumers/CosmeticsQA/ucm136560.htm
- American Composites Manufacturing Association: http://www.acmanet.org/
The personal care products is also closely associated the chemical industry, and as such, similar quality control concerns such as raw material quality, storage, transport, and process disinfection are of utmost importance.
Additional Information:
- Personal Care: http://en.wikipedia.org/wiki/Personal_care
- Cosmeticsinfo.org: http://www.cosmeticsinfo.org
- Canadian Cosmetic, Toiletry, and Fragrance Association: http://www.cctfa.ca/
- American Cosmetics Manufacturers Association: http://www.americancosmetic.org/
- European Cosmetics Association: http://www.colipa.eu/
- Personal Care Products Council: http://www.ctfa.org/
- Health Canada Cosmetics and Personal Care Customer Product Safety: http://www.hc-sc.gc.ca/cps-spc/person/cosmet/index-eng.php
Microbial contamination can potentially cause significant product spoilage issues in personal care products if they are not adequately monitored and controlled. To effectively guard against contamination, a rigorous HACCP program should be put in place to identify all potential areas where contamination can be introduced and closely monitoring them for infiltration.
The QGA method is similar in design to ASTM Standard D4012 for the measurement of ATP in water. The full standard can be obtained here: http://www.astm.org/Standards/D4012.htm.
How can ATP monitoring help?
The costs associated with uncontrolled microbiological contamination can be extremely high. Effective control starts with proactive, quantitative monitoring, which is best executed by rapid test methods. 2nd Generation ATP monitoring provides the most complete and rapid feedback for microbiological management on the market.
This technology can provide you with positive identification of microbiological contamination at the earliest possible juncture. Consider the fact that a standard microorganism at slightly below room temperature will multiple (double) every four hours. This means that during the 2-day incubation period for a standard culture test, a sample that is already contaminated beyond control thresholds will double in size 12 times before a positive test result is known.
Furthermore, you can achieve prompt positive release of batches as soon as possible after filling is completed. This increases efficiency in operations and reduces inventory costs while assuring that microbiological quality specifications are met.
Testing Landscape
Complimentary Methods
- Microscopic examination – characterizing the population using microscopic means is an excellent addition to ATP analyses since ATP tests cannot reveal the presence of certain spoilage microorganisms.
- Specific Culture Methods – while incubation times can be excessive (3-5 days for fungi). In some cases, a certain level of microbial content is acceptable, but the presence of certain species can cause major problems.
Competitive Methods
- Heterotrophic Plate Counts, Dip Slides – Attempts to enumerate the total living population in chemical products using culture-based tests tend to fall short since they only detect 0.1-10% of the total population. In situations where the total population must be kept very low, this underestimation can result in false positives.
Another serious disadvantage to culture tests is the incubation period that is required. The average doubling time for microorganisms found in personal care products is one hour, so the population can grow by several orders of magnitude by the time that culture test results are known.
