Containment, cranes, industrial vacuums, cyclones, clean rooms, tablet presses

Containment in production

Here you will find the most important functions and questions about containment.

What is the definition of containment?

In the case of containers, it must be prevented that reactive or toxic substances escape during processing, thus protecting people and the environment from contamination. In addition to employee safety, the cost-effectiveness of the process is also important. If it is an expensive substance, the loss of a few grams of active ingredient can also mean damage in the three to four-digit euro range.

Using a sealing solution prevents contamination from three directions: operator product contamination, operator contamination from the product, and cross-contamination between different products. In addition to safety aspects for workers at production sites and economic losses due to property damage, consumer protection also contributes to the demand for dust containment systems.

A suitable containment concept ensures that products in the food industry are suitable for allergy sufferers and that there is no cross-contamination from previous processes. For example, local independent production lines are not possible for many operators due to the lack of space and the wide variety of food and beverages demanded by consumers, which necessitates the alternating production of multiple products on the same production line.

How is containment effectiveness measured?

The effectiveness of containment is primarily indicated by two classifications: Occupational Exposure Zone (OEB) and Occupational Exposure Limit (OEL). The OEB specification describes the toxicology of the pure substance and the OEL is the average concentration of the active substance that workers are exposed to during an 8-hour shift.

For example: OEB-5 is the current standard for many applications and corresponds to an exposure of less than 1 µg/m3, i.e. corresponds to the OEL. If you extrapolate this to the size of the Empire State Building in New York, the active ingredient should not exceed a twentieth of a teaspoon in the entire building. However, problems arise when individual companies develop their own standards. Your requirements are sometimes higher than those of the OEB-5 solution. For example, at Roche, the drug equivalent to OEB-5 is called 3B. Without uniform standards, processes are harder to compare and misinformation can result.

How is the effectiveness of containment documented?

While OEBs and OELs typically specify containment goals, measurements are necessary to measure the effectiveness of containment systems and to document the effectiveness of those systems. The Smepac system (Standardized Measurement of Plant Particle Air Concentration) is a method of measuring the concentration of particles escaping from a system. It defines repeatable test procedures and parameters for evaluating and comparing different control processes in a plant.

Accepted test methods use defined lactose levels (other substances are possible), use equipment in a specific environment (humidity, temperature, air exchange rate) and place designated samplers in different locations. The test consists of performing the intended action and collecting air (through the sampler's filter) for 15 minutes.

Analysis of the filter gives a measure of the amount of lactose in the volumetric air that corresponds to the sealing performance of the device. Because the tests run an average of 15 minutes, this performance is known as the STTWA (Short-Term Time-Weighted Average). It is important to note that this procedure captures the total amount of powder that comes out. When using stronger drugs, usually only a small part of the powder mixture is active and the rest is the carrier.

It is therefore important to distinguish between intermittent exposures, such as e.g. when a container with raw materials is docked in a fluidized bed, and permanent exposure, e.g. B. a tablet press, which is not completely safe to distinguish.

Properly performing exposure measurements under containment conditions is key to safely control aggressive pharmaceutical products. Fette Compacting has developed a protective cover for measuring unevenness on tablets. As a result, the functionality of the sealing system can not only be reliably tested, but also planned, which increases planning security for individual projects and thus reduces costs. This method is based on the well-known guidelines of the ISPE (International Society of Pharmaceutical Engineering).

Other factors affecting the packaging are the position of the measuring probe, the position of the operator during the measurement, the number of tablet samples and possible operating conditions, including error situations that may occur. This advanced process ensures a repeatable assessment, especially when sealing tablet systems. As a result, drug manufacturers reduce the set-up effort, test set-up and any post-production enhancements.

After successful testing, the systems receive a containment protection certificate. The certification levels are based on the OEB safety pyramid limits and acceptable daily exposure values (PDE). The measurement protocol is the basis for the operator to assess the risk and to significantly reduce the amount of work after the system has been commissioned.

What does containment look like in practice?

Looking at the system and its components, it becomes clear that throttling is primarily about interfaces and how to avoid them. Because with every transition from one component to another there is a possibility of leakage. Knowledge is required to select the right and economical location solution. For example, to answer the question of whether the process should be organized in the classic way in stainless steel or in single piece technology.

Because in addition to permanently installed isolators and production systems that have to be cleaned after use, it is now possible to organize complex processes with flexible membrane systems that are not cleaned after use. Operators who want to reuse their parts need to clean them safely. There are also two options or philosophies: expand everything and clean, or implement integrated systems that can be cleaned.

All options have advantages and disadvantages. Which solution is the best for a specific application depends on many parameters such as product properties, production quantities or economic considerations. Additionally, in a highly regulated pharmaceutical manufacturing environment, any change to the process requires re-examination, which pharmacists try to avoid.

When it comes to containment, companies have many options to choose from that are suitable for their custom production. The overriding principle here is to minimize the amount of material that escapes from the production plant. Mainly for workers' health and does not contain any harmful substances to save costs.