When shifting lively pharmaceutical elements (APIs) and different delicate supplies round throughout pharmaceutical manufacturing, professionals fear about waste, effectivity and materials integrity. ChargePoint Technology’s PharmaSave break up butterfly valve is designed to assist streamline materials switch and eradicate worries about yield, contamination and different points.
Mike Avraam, head of options engineering for ChargePoint Technology, advised Outsourcing-Pharma that when coping with extremely potent substances like APIs and extremely potent APIs (HPAPIs) in a fancy manufacturing atmosphere, corporations face a lot of challenges.
“During material transfer, effective engineering controls are crucial as employee safety is the primary focus,” he stated. “However, companies also aim for minimal disruption to the manufacturing process.”
Avraam identified that barrier applied sciences, like isolators and restricted entry barrier techniques (RABs), can present ‘micro-environments’ that will supply higher ranges of safety and integrity in processes than conventional 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 defined.
SBVs are designed to stop contamination, operator contact, and cross-contamination of merchandise in multi-use amenities. The circulation of supplies could be advanced in solid-dose manufacturing and different processes, and the SBV helps improve security, improve yield and keep away from expensive waste.
According to Avraam, each halves of the butterfly valve are mixed throughout powder charging, which is meant to allow contained, environment friendly supplies switch.
“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 advised us, including that containment integrity is the first problem within the course of.
The firm experiences that the PharmaProtected valve line is independently validated by third events, in line with the ISPE Standardised Measurement of Equipment Particulate Airborne Contamination guideline. This guideline is meant to benchmark the efficiency of kit capabilities.
When dealing with HPAPIs, materials could also be moved between amenities, often throughout geographical boundries. Devices just like the SBV valves, Avraam stated, can assist make sure the integrity of expensive, delicate powders from place to put.
“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.”