Butterfly effect: why split butterfly valve provides a cost-effective sealing solution

More and more new drugs contain highly effective active pharmaceutical ingredients (API), which require careful handling and use of specialized equipment. Here, Precision Polymer Engineering (PPE) focuses on why split butterfly valves provide cost-effective solutions and an in-depth understanding of the best sealing materials for the sealing process.
A large part of the new drugs under development contain highly effective active pharmaceutical ingredients (APIs), leading to explosive growth in demand for their production.
However, the cytotoxicity of APIs presents many challenges, including the handling of the ingredients and the need to invest in specialized containers to ensure that employees and their work environment are not exposed.
What is the driving force for a better containment process, and what are the challenges facing manufacturers?
The increase in the number of highly active substances and stricter regulations on operational and environmental safety have led to a significant increase in the global demand for sealing devices.
Increasingly effective drugs require the industry to make major changes to plant design and operating procedures to ensure adequate containment. However, current expectations for containment levels often far exceed the capabilities of equipment designed and manufactured a few years ago.
When selecting sealing components for high containment applications, one must consider the potential problems that may arise in the event of leakage or valve seal failure:
Highly effective active ingredients such as hormones, retinoids, certain antibiotics and certain anesthetics require special control during processing. This is defined by the occupational exposure limit (OEL) or occupational exposure band (OEB) assigned to the active drug substance.
Historically, personal protective equipment has been used for risk protection. However, while it is undeniably important to provide protection for employees, there is a risk of cross-contamination in the work area due to product transfer from protective clothing and uncomfortable working conditions.
In order to protect equipment operators and reduce product contamination levels from micrograms to nanograms, it is necessary for the pharmaceutical industry to advance its containment strategies.
However, challenges may arise when trying to find containment solutions for existing equipment and facilities. Based on this consideration, PPE believes that adding SBV can prove to be a cost-effective solution, especially when space and existing equipment constraints limit the available options. These valves have proven to be able to meet the containment targets required to handle the API.
During the transfer of effective powder from one process step to the next, SBV minimizes the amount of particles exposed to the air. A basic feature of all SBVs is that they are composed of two halves that are connected together, namely the active “Alpha” unit and the passive “Beta” unit.
Each half is composed of half a “butterfly” disc, and the butterfly disc is sealed on the main body with an elastic seal to form a highly sealed facility. Elastomeric seals are used as “seats” within each half, and once butted together, provide an effective seal between the active and passive halves.
Valves and their elastomer components are often exposed to various chemicals and solvents, such as corrosive cleaning agents. Therefore, the chemical compatibility of elastomer materials in any sealing process is a crucial design consideration.
Valve manufacturers have long relied on materials such as EPDM (ethylene propylene terpolymer) as the preferred material for pharmaceutical SBV valve seats. However, as the effectiveness of APIs increases, more elastic elastomer materials are required.
PPE recommends the use of perfluoroelastomer (FFKM) valve seats in such chemically corrosive applications. The excellent mechanical properties of FFKM, combined with almost universal chemical resistance (similar to PTFE) and excellent thermal properties (from -30 °C to +325 °C), make it ideal for SBVs used in high-efficiency API processing environments select.
Through simple equipment and material considerations, such as using FFKM seat instead of EPDM seat in SBV, it is possible to expand the operating capability of the high hermetic valve without expensive redesign.


Post time: Jul-08-2021

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