When moving active pharmaceutical ingredients (APIs) and other sensitive materials around during pharmaceutical manufacturing, professionals worry about waste, efficiency and material integrity. ChargePoint Technology's PharmaSave split butterfly valve is designed to help streamline material transfer and eliminate worries about yield, contamination and other issues.
Mike Avraam, head of solutions engineering for ChargePoint Technology, told Outsourcing-Pharma that when dealing with highly potent substances like APIs and highly potent APIs (HPAPIs) in a complex manufacturing environment, companies face a number of challenges.
“During material transfer, effective engineering controls are crucial as employee safety is the primary focus,” he said. “However, companies also aim for minimal disruption to the manufacturing process.”
Avraam pointed out that barrier technologies, like isolators and restricted access barrier systems (RABs), can provide ‘micro-environments’ that may offer better levels of protection and integrity in processes than traditional open environments.
“Many pharmaceutical companies are finding that the use of split butterfly valve (SBV) technology integrated to either the isolator or RABS for the transfer of material in or out of the manufacturing process increases the integrity of the containment solution,” he explained.
SBVs are designed to prevent contamination, operator contact, and cross-contamination of products in multi-use facilities. The flow of materials can be complex in solid-dose manufacturing and other processes, and the SBV helps increase safety, increase yield and avoid costly waste.
According to Avraam, both halves of the butterfly valve are combined during powder charging, which is intended to enable contained, efficient materials transfer.
“Transferring material from one closed system into a separate closed system is one of the key difficulties in powder transfer. It’s important to ensure that the design specifications of the technology or device used in this process will meet the required accessibility, batch size and containment performance,” Avraam told us, adding that containment integrity is the primary challenge in the process.
The company reports that the PharmaSafe valve line is independently validated by third parties, according to the ISPE Standardised Measurement of Equipment Particulate Airborne Contamination guideline. This guideline is intended to benchmark the performance of equipment capabilities.
When handling HPAPIs, material may be moved between facilities, occasionally across geographical boundries. Devices like the SBV valves, Avraam said, can help ensure the integrity of costly, sensitive powders from place to place.
“To overcome this challenge, ChargePoint Technology has introduced a single use version of the passive half of its SBV, the single use passive (SUP)," Avraam said. "This ready-to-use, off the shelf solution provides a method of contained powder transfer within facility A (drug supply) and can also be used as a product’s primary packaging and container closure for transportation to facility B (drug product formulation); in short, it provides CMOs and in-house manufacturers with the ability to handle ingredients with less risk due to the elimination of the double handling concern.”