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Containment trends and technologies: Dr Torsten Schmidt-Bader, Director of GMP-Compliance & Validation at NNE Pharmaplan, discusses the trends in containment technologies seen recently in pharmaceutical processing.

Containment technology has emerged as one of the major trends in the processing and manufacture of pharmaceuticals. Companies approach containment through an array of technologies and processes: from air suits to integrated isolators and simple procedural methods, pharmaceutical processors are searching for new and different ways to reduce the exposure of employees to harmful substances as well as minimizing risks of cross-contamination which can impact product quality.

In a series of questions and answers, Dr Schmidt-Bader discusses the evolving trends that are generating greater interest in containment as well as some of the new technologies helping companies to address the issue more efficiently.

Pharma: Is there a greater need for containment in drug production today than say 10 years ago?

Schmidt-Bader (SB): The landscape of pharmaceuticals has changed significantly in that time period. Pharmaceuticals are becoming increasingly more targeted in their applications. For example, many oncology drugs are designed to target only the effected cells. These types of drugs tend to have larger molecules and, thus, are more potent.

In addition, a rise in biopharmaceuticals and anti-viral medication requires minimal doses because they are highly potent in nature. These drugs, such as cytotoxic agents and hormones, have a higher risk of cross-contamination from harmful dust exposure.

These volatile substances are also growth markets. In fact, there are 245 pure vaccines and 11 combination vaccines in development today. With fears of worldwide pandemics and large foundations funding vaccines on a global scale, this market is set to accelerate production in the near future. only ten years ago just 5% of drugs were seen as high potent, today nearly 30% of all APIs are considered high potency.

At the same time, greater emphasis from governments and from companies has been put on worker safety. So while volatility is increasing, tolerance for exposure has decreased markedly.

Pharma: What are some of the changing approaches to containment given this increase in more potent drugs?

SB: not unlike drugs, containment has become more targeted. In the past 15 years or so we have seen facilities move from large clean room models to much smaller containment areas. This was first driven by the need to maintain greater sterility. However, for solid capsule filling, for example, this is necessary in order to contain particulates that are inevitable during the filling process. Greater containment has led to increasing interest in isolators as an option.

Pharma: What are some of the recent developments in isolation technology?

SB: Automation and integration are definitely two areas of technological development. The more processes that are automated, the more they can be isolated from human contact which, of course, reduces the risk of cross-contamination. For example, post-production cleaning can also be automated--further extending the benefits of isolation. Automatic cleaning actually starts with eliminating unnecessary waste. Systems can employ a simple "no cap / no fill" function, which means that the capsule filling function doesn't activate if a capsule isn't present. Another function essential to automatic cleaning is a 316L stainless steel production, which allows cleaning with strong acids, caustic solution, and 80[degrees]C desalinated water.

Some automatic cleaning systems employ a closed system of telescoping spray nozzles and drains. The entire sealed system sits on a drain bevel with draining and suction. Various parameters can be saved depending on the product being filled. All of these elements result in a 'one-button' cleaning process with repeatable results every time it's used.

PAT (Process Analytical Technology) is another form of automation that both increases quality as well as improves safety. PAT introduces inspection and controlling systems throughout an entire process, called closed loop control; nothing advances to the next step unless a problem is either fixed or a faulty element is rejected from the system.

The industry offers an array of equipment that allows for effective in-line analysis and control of critical process parameters for filling capsules and liquid pharmaceutical products. Using solid capsule filling as an example, filling process quality parameters are monitored and controlled. In preliminary sorting, capsules of a sub-standard quality are identified and eliminated. Compressed air and vacuum-monitoring units constantly check operating pressure and stop the system before malfunctions arise. An NIR (near Infrared) system verifies the active ingredient content, and the filling weight is monitored by a check weighing system operating in closed-loop control with the filling system to automatically increase or decrease the powder-dosing amount to match the correct specification. Problems are not just identified, they are fixed along the way in a closed loop, which identifies faults before they can significantly reduce downtime.

Integration is another rising trend alongside automation. An integrated isolation system ensures that many of the automated elements I spoke about before work seamlessly together.

Pharma: Generally, how are containment levels measured?

SB: For worker safety, levels of exposure are measured in OEL (occupational Exposure Limits) Levels. OELs are measured from a level of 1 to 5. An OEL Level 5 exposes workers to < 1 [micro]g/ m3 of active products in workspace air over an 8-hour shift. Ideally this level of OEL should be achieved with no special worker protection clothing required.

Pharma: What is the process for determining what levels of containment are necessary?

SB: At Pharmaplan we use a multi-step process that begins with evaluating the type of product being produced but then also investigates what the future plans are for the operation. For example, there are modular filling systems with integrated isolators coming onto the market that may be appropriate for operations that have isolation needs today for one type of product but may also need to expand or change operation very quickly for another.

Also, it is very important to evaluate the total cost of containment. For example, air suits are sometimes a very economical initial solution, however, the long term costs in efficiency could outweigh initial investment in an isolation system. After all, workers can only operate in the suits for a maximum of two hours. Features, such as automatic cleaning, are another investment decision that is not strictly a cost-to-cost comparison. This type of feature can save significant time in production and the results can be duplicated more or less exactly each time.

For more information:

Torsten Schmidt-Bader, PhD is Director GMP-Compliance & Validation at NNE Pharmaplan. He studied both pharmacy at the Philipps-Universitat Marburg (Hessen) and Food Chemistry at the Westfalische Wilhelms-Universitat (WWU) Munster (Nord-Rhein Westfalen). He received his doctorate at the Humboldt University of Berlin with a doctoral thesis specializing in pharmaceutical chemistry.

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Title Annotation:containment
Author:Schmidt-Bader, Torsten
Publication:Pharma
Geographic Code:4EUUK
Date:Jul 1, 2008
Words:1186
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