What is containment?

Containment is the separation of a hazardous area from a clean one by means of a physical (isolators) or aerodynamic (downflow booths) barrier.

While processing pharmaceutical powders, highly toxic pharmaceutical powders may be handled, and it is essential that they are effectively contained so that they do not leak into the surrounding environment and the operator can work safely. For this reason, containment strategies must be put in place, that is, applying a barrier between the hazardous area and the clean area to thus protect the operator while handling potent compounds and toxic substances.

Containment is an issue more and more addressed by authorities and companies in fine chemical and pharmaceutical industries with increasing demand also in energy, aerospace, food and cosmetic applications. Product protection, as well as environment and operator protection, is the driving requirements in new projects or in equipment re-vamping. Containment strategies must be implemented to minimize his or her exposure to API, which must be kept below safe limits. When handling sterile products, the containment process must significantly reduce the exposure of the product to its surroundings and ensure the total safety of the finished product.

What is an isolation system?

An isolator is?an enclosed and confined environment?whose function is to provide a threefold level of protection. It’s designed for handling toxic substances, pharmaceuticals or pathogens and capable of isolating and protecting the operator, the environment and the product.

FPS offers a complete range of containment systems that satisfies all possible needs and requirements. Our approach to a containment system is to discuss with the end user the specific needs in terms of protection, quality, and productivity in order to identify the equipment that best fits the specifications:

• Isolators for API and HPAPI Primary Production?are available for many applications: Laboratory, Synthesis, Filtration & Drying, Production Reactor Charging, Process vessel discharging, Pilot Milling & Micronisation, Production Milling & Micronisation, Dispensing, etc.
• Isolators for HPAPI Formulation and Packaging?are available for many applications: spray dryers, granulators, extruders, mixers, powder screens, tablet presses, capsules filling and pan coating machines.
• Isolators for sterile applications?are proposed in the form of closed isolators or Restricted Access Barrier Systems.
• Additional containment solutions?as: Laminar flow booths for small volumes protections, Pack-off systems to safely discharge, weigh and pack powders, Cleanrooms as general operation environment and Inert Gas Containment systems.

Containment systems enable the operator to work with highly toxic powders (HAPI and HPAPI) or sterile powders with safe and efficient manner: they work under negative pressure, that is, they prevent the material processed inside from being released outside to ensure that the operator handles the powders in a fully safe manner and prevent the toxic substances from escaping into the surrounding environment. An aseptic isolator provides a completely sterile environment for carrying out aseptic processes, i.e., aseptic handling of active ingredients, in order to maintain constant sterility of the product being handled.?

How do you define a containment strategy?

The definition of the proper containment strategy is a?necessary requirement?for the correct design of the facility and the process equipment. Containment is necessary?to reduce the exposure of operators to potent products.

A containment strategy determines all the conditions for performing the handling of pharmaceutical powders with a totally safe manner for the operator, the surrounding environment, and the product.?Defining a containment strategy starts with the characteristics of the products to be handled, occupational exposure limits (OELs), the amount of powder involved, and the duration and frequency of the handling process. Such a strategy can be implemented either on new machinery or on process equipment that was not designed for containment.

The starting point is the sound knowledge of the products to be handled and their specific characteristics as well as their occupational exposure limits (OEL), the quantities involved and the duration and the frequency of each process to be contained. Powders are extremely volatile and can be easily inhaled, so it is essential that proper PPEs are worn and a separation system is used to minimize the quantity of product the personnel is exposed to. The choice of such system is mainly based on the?potency of the compound: while non-potent products may require equipment as simple as a downflow booth, highly active APIs must be handled within a rigid isolator. The longer or the more frequently a task is performed, the higher is the potential exposure of the operator to the product. If the substance is potent a?rigid wall isolator is essential?to minimize the exposure, while less potent products require different containment strategies.

Process equipment not designed for containment can be fully or partly integrated in isolators. A technical evaluation and a close cooperation between the equipment manufacturer and the isolator maker can lead to excellent containment performances. Once the systems are installed, one can run the SMEPAC tests, which will simulate the entire process with a placebo compound. SMEPAC tests?are carried out simulating the whole process using placebo compounds. Specific sensors are installed in the room, close to the breathing area of the operator and on the sensitive areas of the containment systems to measure the total exposure of the operator and verify that the measured value are not exceeding the maximum exposure limits of the APIs.

Would you like to test a small batch of a new product? Schedule a trial in our MEC (Micronization Excellence Center): [email protected]

Let us find the perfect fit for you!?