SMEPAC Monitoring.

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Containment and capability: two words that tell the story of CSV Containment’s world, but they also summarize the meaning of SMEPAC monitoring, aimed at verifying the safety of operators and equipment.

Indeed, SMEPAC monitoring (Standardized Measurement of Equipment Particulate Airborne Concentration) is aimed at measuring the particulate containment performance of isolation systems used in the pharmaceutical production of highly active substances. CSV Containment’s extensive experience in the field makes it an increasingly competent and qualified player. Ten years of experience in designing, building, and installing containment systems, both rigid and flexible, ensure in-depth knowledge of the subject and predictive ability about the goals that can be achieved with monitoring.

Internal and external monitoring tests.

Being manufacturers of isolators, we test our machines by default because we want to ensure the safety of the products we sell, but also to accumulate experience and know-how. We boast a very rich history of installations that differ in shape, size, materials, and uses; we have case studies for every situation, data, and monitoring that also guide us in the development of new containment solutions and products, as in the case of the proprietary Twin Tie® separation systems or DIT technology.

We also perform internal testing to improve our knowledge of performance related to the technology choices we make and the correlation between batch size, containers, and transfers. We believe that providing products with assured and documented performance is critical for customers, who are already provided with a useful set of data to help them decide whether to proceed with further testing or to assess how to best use the systems.

CSV Containment also offers SMEPAC monitoring service on externally supplied equipment, both for customers and for other manufacturers in the market. Testing is a standardized methodology that evaluates the containment performance of particulate material within rigid insulators, flexible insulators, and any other device used in the world of Isolation Technology. We can conduct tests on SPLIT valves, transfer interfaces (Rapid Transfer Port), and separation systems, but also on techniques and procedures typical of the active world such as safe filter change, bag in bag out, and so on.

Attention to detail.

Not only attention to particles but also to particulars. Through years of collecting and analyzing data from SMEPAC monitoring, in a wide variety of configurations, our team can envision the performance to expect and define robust and structured sampling plans. By analyzing critical points, and potential leakage points, and based on the expected transfers and devices used by the machine configuration, we can identify locations for performing the most significant sampling, On Air (Air Sample), and swabs on the chosen surfaces. The latter is very useful and supports the interpretation of On Air sampling data.

Key moments in the operations to be monitored are considered and customers are directed to adopt special expedients useful in ensuring or improving performance. These expedients sometimes improve the operation itself and the ergonomics of the operator, going beyond the measuring function of the test. This leads to actual operator training, which can determine the achievement of targets in the tests and especially ensure their maintenance in actual production.

Case histories.

CSV Containment has a very rich database of case histories on SMEPAC testing, such that we can determine the type of target attainable by analyzing several factors, starting with the configuration of the isolation system. Many are the variables:

  • The technologies used (RTP, Split valve, liner, separation systems, number of working and inlet-outlet chambers, vacuum conditions, and others)
  • The characteristics of the material to be handled (particle size and volatility for example)
  • The quantities involved (Batch Size)
  • The objects and containers to be transferred from/to the isolation chamber (drums, bags, small containers or bottles, etc.)
  • The ergonomics of the setup (position of gloves and carpentry relative to the operator, combined with the operations to be performed)

To this set of considerations must be added the client’s culture and experience in handling highly active substances. All these attentions have resulted in many national and international entities choosing CSV Containment’s monitoring services over time, but there is also an additional reason.

Certain and quick results.

A key component in ensuring the outcome of monitoring on time and with reliable results is that related to laboratory analysis. Few companies can boast a dedicated analysis line to serve their customers in time to get productions up and running quickly.

The last piece needs to be the highest performing, and for this CSV Containment co-owns an HPLC line in PolyCrystalLine’s accredited testing laboratory. Analysis of all samples from our monitoring thus travels on a “reserved lane,” thanks to an exclusive agreement. Our services then become immediately available on several surrogates such as lactose, mannitol, and naproxen, whose analytical methods have been validated in the laboratory. We are equally able to use any other placebo or real product as long as a 10-gram sample of the material and its validated analytical method are available. This allows SMEPAC monitoring to also be carried out under real-world conditions, making it possible to shorten the time it takes to set up a production process related to highly active substances for which to ensure the safety of no exposure to operators and surrounding environments.

CSV Containment provides tailor-made solutions for pharmaceutical and fine chemical sectors in terms of containment. For more info: containment@csv-ls.com

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