Microbial contamination can be a devastating issue for a pharmaceutical plant, resulting in sicknesses, fatalities, and damaged reputations. The ideal aim is to prevent contamination from becoming problematic.
The issue can stem from numerous sources. For example, a fiber could cause physical contamination, while moisture or gas could cause chemical-related impurities. Moreover, biological contamination could include problems related to viruses or mold.
One of the difficulties of finding contaminants is that any piece of equipment or step in a process can introduce them. If a product requires processing inside a reactor with an oil leak, that equipment could expose the contents to a contaminant. Similarly, an employee may mistakenly clean a machine with biologically contaminated water or fail to wash their hands thoroughly after using the bathroom.
However, actionable strategies exist for detecting contamination efficiently and effectively. When those aims happen, it’s less likely that contamination will cause substantial issues.
Learn what works for other companies
Staying on top of contamination risks requires knowing the most reliable ways to detect problems.
An MIT consortium recently published a study to assess 18 protein drug contamination incidents. The content also explored the best ways to prevent similar events from occurring again.
For example, the research confirmed that the most common test used to detect viral contamination took two weeks to deliver results. That long timeframe means there’s more opportunity for an impurity issue to cause more extensive problems. However, some companies use another faster method based on polymerase chain reaction (PCR) technology.
Since that test looks for specific DNA sequences, it’s most appropriate when company representatives know which viruses are most likely to affect their factories. Other businesses use tests that screen for a broad spectrum of viruses, making them sensitive to more types.
Some pharmaceutical plants take a preventive approach with a process that removes or inactivates viruses on mediums before bringing them into the production process. Ultraviolet light or nanofiltration can do that, as can a process called high-temperature-short-time treatment. That latter possibility works similarly to pasteurization.
Have samples thoroughly analyzed
Microscopy and spectroscopy analyses are methods that can help pharmaceutical representatives confirm the type and level of contamination present. However, the suspected contamination affects what kind of analysis a professional chooses.
For example, specialists typically select microscopic analysis for visible physical contamination. A person might notice that a batch of white tablets has unusual black specks in them, so examining the products with microscopy tests can narrow down the possible causes of the impurities.
In other cases, in-house batch testing and other quality control measures can indicate the possible presence of invisible contaminants. Then, chemical testing through options such as infrared spectroscopy or high-pressure liquid chromatography can allow learning as much as possible about the issue. After that point, it’s easier to identify what went wrong and the best ways to prevent future problems.
Techniques to analyze contamination don’t always result in identification. However, professionals can still provide useful information, such as which methods they already used to determine the impurity’s nature or which step in a process may have caused the issue.
Recognize the role of packaging
Pharmaceutical representatives also get alerted to potential contamination associated with packaged products. The type of packaging used determines the most appropriate detection methods. However, X-rays and metal detectors are among the most common options to find objects that cause contamination.
Selecting the right packaging is an excellent preventive measure against contamination. For example, some medical devices, such as stents, have coatings of medications on them, thereby doubling as pharmaceutical delivery devices. Medical devices used internally must withstand the body’s harsh environment without triggering immune responses in a patient.
Parylene is a polymeric material often used to coat electronic devices as well as medical products. Numerous studies indicate that parylene is a good choice for medical packaging or a coating on a biomedical substrate. Parylene C and N comply with FDA regulations for biomedical use. The material will not break down in the corrosive environment inside the body.
Avoiding contamination also requires selecting a thoughtful design for the package. One study investigated several packages to see which ones were least likely to introduce contaminants when people opened the material to take out the contents. The results showed that packages made to curl outward after opening caused fewer contacts with non-sterile surfaces than inward-curling designs or those with tabs.
This example shows that minimizing contaminants may mean taking user feedback into account and basing package redesigns on what they say. Even if a product does not become impure at the factory level, pharmaceutical company representatives should still ensure that a poor packaging design does not increase preventable dangers for patients.
Check contamination rates with environmental monitoring
Staying abreast of contamination levels and addressing problems before they get out of hand is also an essential detection method, particularly through environmental monitoring.
More specifically, microbial limit tests assess how many and what type of viable microorganisms exist in non-sterile parts of pharmaceutical plants, cosmetics manufacturers, and other facilities that must take extra care to safeguard against impurities. This method of checking microbial bioburden levels requires assessing the air and surfaces.
Taking samples for these tests involves selecting them randomly from the relevant product, then mixing them. However, when a product contains antimicrobial ingredients, those must be dealt with through dilution or inactivation before running the test. The results show whether the quantitative limits of certain microorganisms are within acceptable limits or exceed them.
Alert levels indicate established levels of microorganisms that may signal a departure from normal operating conditions. In contrast, action levels mean a process is outside of its expected operating range, and that condition caused elevated levels of microorganisms. Thus, an excursion rate indicates the percentage of environmental monitoring samples that exceeded the acceptable microbial count at a given time.
Excursion rates can help you determine if a certain process may need further investigation. However, bear in mind that this testing method only shows a part of the overall circumstances because it focuses on a small part of the pharmaceutical process rather than the facility at large. Microorganism counts can and do change due to factors like seasonal variations and new equipment. Knowing when they get too high could help you determine when and how to take the next actions.
Detecting contamination requires an ongoing effort
These examples and tips show that responsible parties must engage in a conscious and continuous effort to find evidence of microbial contamination and keep it at bay.
Making progress means examining processes and packaging designs, training employees to follow the right procedures, and understanding which tests are most appropriate to screen for possible contaminants.
Moreover, understanding what industry peers do to minimize issues and staying aware of advancements in detection methods will help company decision-makers achieve their goals.