“CONTAINMENT” IN PHARMACEUTICAL PRODUCTION & TIẾN TUẤN’S SOLUTIONS

What is pharmaceutical containment?

(tientuan.com.vn) - Pharmaceutical production has deeply changed since the last two decades, with highly potent active pharmaceutical ingredients (HPAPIs), especially in new products, increasingly playing a central role in the fight against many serious diseases, such as cancer drugs. These active ingredients are found in very small amounts but with high potency that can cause significant adverse effects on humans or the environment. However, the flip side of these innovations is the need to protect workers who handle HPAPIs along the entire life cycle of the drug product manufacturing, from synthesis of the pharmaceutical active ingredient, production to distribution of the finished medicinal product.

The terms 'containment' and 'isolation' are often used interchangeably to describe equipment or systems that prevent release of hazardous materials. It describes the process of containing a substance within a defined space, a method that is suitable for protecting operators and the environment in case of high toxicity and product reactivity.

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Why containment is needed in pharmaceutical manufacturing?

The description potent is generally used of a chemical that produces significant physio logical, toxicological or pharmacological effects on the body even if present in very small quantities. Such effects may be beneficial to a patient receiving a controlled dose of a drug but are liable to be hannful to workers manufacturing the drug who are exposed to uncontrolled quantities of it. Thus a substance that is of benefit to a patient could in effect become toxic to a worker.

Contamination is a major issue for pharmaceutical companies, particularly in multi-process plants. Poor containment can force plant closures and cause companies to suffer huge financial losses as a result. A closure at the Genzyme plant in 2009 resulted in up to $300m in lost sales after a virus contaminated a bioreactor.

Containment in solid manufacturing process

With tablet manufacturing process, the ingredients go through as many as 9 different machines to become a usable tablet. Wet granulation, the most commonly used method, involves dispension, wet mixing, wet mill, drying, dry mill, final blending, tableting, tablet coating, blistering, and cartoning, with ingredients being transferred from one machine to another, giving plenty of opportunities for powder to escape.

The use of chemicals and potency comes with many risks, both for the personnel performing the activity and the environment around them. As a result, pharmaceutical manufacturers tend to use specialized equipment to contain, isolate to prevent these materials from coming into contact with people and unwanted areas, helping to protect from unexpected harm to employees and to the factory.

Levels of containment

Depending on the toxicity of a substance, a device can be designed to integrate with an isolator or alternatively, analyze risks to control dust generation during operation, troubleshooting and equipment maintenance and maintenance below the allowable threshold. For example, tablet coating machine can be designed to allow closed feeding, closed sampling, automatic cleaning (WIP/CIP) and safe change filter. Depending on HPAPI specifications, equipment suppliers will provide a suitable solution.

Tien Tuan’s solutions in containment

In the world pharmaceutical industry, more than 60 percent of pharmaceutical products are produced as tablets, capsules, lozenges or similar solids. Toxic compounds can be inhaled, absorbed through the skin or ingested. As a manufacturer of pharmaceutical equipment, Tien Tuan’s approach is to look at the product characteristics, and analyze the risks in the production, cleaning, maintenance, and servicing of the equipment to get the necessary solutions. tailored for each customer.

Depending on customer needs and product characteristics, Tien Tuan provides different containment or isolator solutions. With granulation lines, Tien Tuan offers a complete package of integrated line with isolator or closed containment solutions with closed IBC feeding and discharging, connected by containment valves, WIP/CIP, closed sampling,... Similarly, with tablet coating machine, the isolator is integrated with the machine or closed design solution for synchronous containment, CIP, closed sampling, safe filter change.

However, when it comes to containment involving highly active substances in the pharmaceutical industry, it is essential to assess containment accurately and understand the consequences if containment measures are inadequate. All aspects of substance toxicity such as building requirements, ventilation systems, exhaust gas treatment systems, and above all, management of operating procedures - troubleshooting – cleaning- maintenance –must be taken into consideration and followed.

In addition, pharmaceutical manufacturers must look to the present and the future. The containment concept should ideally consider having a higher safety rating than is required for the corresponding product to allow for future adjustments. In the future, open production processes will no longer be possible or even approved for the production of substances with increasing potency.

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Tablet coating machine under Isolator made by Tien Tuan.