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In this case, we are looking at an incident at ProTek (name changed for the confidentiality of the business), a Biotech CRO company which produces a diverse range of small production batches set to customer specifications.
To fulfill orders, ProTek makes wide use of purified water in the process, and also as a component of the final product.
The ProTek production system is advanced, capable of delivering highly purified water at 9 points of use via a recirculation loop. The purification train includes a softener, filtration, reverse osmosis, electrodeionization, a 0,22um vent filtered tank feeding a recirculation loop with an online 0,2um membrane filtration step.
The entire system is decontaminated monthly with a caustic and hydrogen peroxide solution then rinsed until pH approaches 7.
ProTek monitors the system parameters (resistivity, RO rejection, etc.), but no microbial tests are performed.
One of ProTek’s products has a specification for low levels of pyrogens. Microbial pyrogens are produced by bacteria, some of which can form hard-to-remove biofilms on surfaces. Since water is the biggest potential contributor to microbial pyrogens, ProTek was controlling water quality prior to processing with a portable rapid endotoxin detection system supplied commercially from a leading company.
One Monday, a ProTek employee noticed a pyrogen result for the water at the point of use was OOS (Out-of-Specification).To identify the source of the contamination, pyrogen tests were performed at other sampling points, including the tank outlet, the DI outlet, the RO system. Results were within spec for all sampling points, except for the storage tank, making it the primary suspect.
ProTek halted production, decontaminated and rinsed the system, giving time for the storage tank to refill and for the water quality to be controlled again.Pyrogen levels were back within specification, but the batch was processed 24 hours behind schedule, putting pressure on the downstream operations to be completed that week.
2 weeks later, before the processing of another product with similar pyrogen requirements, test results showed a new contamination event, with excessive levels of pyrogens.The same curative measures were implemented before production could be resumed.
When water quality is OOS, the batch in production is processed with a delay of 24 hours, which puts pressure on downstream operations.
The investigation plan involved microbial testing of various points:
The sampling plan established:
Due to a lack of appropriate microbiology capabilities, the investigation was conducted using a pyrogen detection device. This solution is expensive and not ideal, since pyrogens (lipopolysaccharides) are produced only by gram negative bacteria such as pseudomonas, but not micrococcus, hence the results did not reflect the total microbial population in the water.
ProTek’s investigation was conducted over the course of a couple of weeks until the prime suspect was identified:
As a result of the investigation, the following control measures were implemented:
The measures and control plan were effective in preventing the reoccurrence of the contamination problem, allowing ProTek to avoid further setbacks in its production schedule.
A biofilm in the storage tank was the cause of the recontamination.How did it form in the first place?
The insights from ProTek’s case may alert us to other equipment for which complete sanitization or drying may be difficult and open the door to contaminations:
Pseudomonas aeruginosa is a common gram-negative bacterium that can cause disease in plants and animals, including humans.
It is found in soil, water, skin flora, and most man-made environments throughout the world. It thrives not only in normal atmospheres, but also in low-oxygen atmospheres, thus has colonized many natural and artificial environments. Because it thrives on moist surfaces, this bacterium is also found on and in medical equipment, including catheters, causing cross-infections in hospitals and clinics. It is also able to decompose hydrocarbons and has been used to break down tarballs and oil from oil spills. P. aeruginosa is not extremely virulent in comparison with other major pathogenic bacterial species but is capable of extensive colonization, and can aggregate into enduring biofilms.
This Use Case is based on a true story! (Though we edited it for readability and, of course, for confidentiality.) We like to tell stories about real situations because we think they help translate raw facts into helpful insight and understanding. We’re providing this use case as an illustration, but it does not imply that the same conclusions can be made in similar cases. We will be happy to discuss it, however, as well as how the particulars of this case might be transferable to your situation—so don’t hesitate to contact us! Also, please be aware that we do sometimes use automatic translations, which might slightly distort the information.
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