Dec Case Study: Multi-Process Isolation Solution

Dec Group has developed an effective three-chamber isolation system that provides high containment during reception, milling and dispensing of product following filter drying.

The solution harnesses Dec’s expertise demonstrating a proven track record in managing highly technical and challenging isolation projects.

Requirement: Rapid transfer and flexible processing in total isolation

A customer active in hormone production needed an appropriate solution for grinding material and clean packaging in isolation following the filtering and drying process.

Customer requirements included:

• Safe barrier between operator and active drug substance to provide both operator and product protection
• System suitable for multi product use with OEB5 category potent compounds
• Isolator designed for automated discharge and manual heel removal, milling and dispensing of product discharge from filter drier
• Enable manual sampling via the filter dryer sampling port, integral with discharge hatch
• System to mill and pack other products introduced to the isolator via a RTP Rapid Transfer Port
• Operation in an inert atmosphere during product discharge
• Whole process plant to be Clean In Place (CIP) enabled

Dec Solution: Three chamber isolation

Dec’s solution is based around a three-chamber isolator to provide a high containment environment during automated discharge from filter dryer and transfers between agitator, milling and dispensing processes.

The isolator has been designed to offer a DEL (Design Exposure Limit) under 50 ng/m³ of time weighted average andan STEL (Short Term Exposure Limit) less than 25 ng/m³ for operations lasting less than two hours.

The filter dryer outlet port ensures smooth and free-flowing transition from the filter dryer to the isolator’s upper chamber, which is designed to receive and mill the discharged product. It further includes the weigh system indicator panel as well as a DEC MPTS sampling system for taking samples of the milled material. Glove-guards prevent operator entrapment when the filter dryer agitator is running.

The middle chamber houses the weigh platform and a Dec continuous liner pack-off head for primary containment. Both middle and upper chambers include Rapid Transfer Ports (RTPs) for product and sample transfers into and out of the containment system, along with independent isolator differential pressure controls and HEPA filtration systems.

Total containment/isolation

All chambers are designed to operate at a negative pressure and with nitrogen purging during processing. Once the target weight is reached and the endless liner is sealed, product passes into the lower chamber through another continuous liner/bag connection. The material is therefore double packed and sealed to achieve very high containment levels before leaving the enclosure in sealed drums. A roller system allows for easy drum manipulation.

The isolator and process equipment cleaning is essentially designed for Wash In Place, using provided spray balls and spray guns.

The isolator is installed within an Atex classified area and is controlled via a PLC with operator interface via a touch screen HMI. Due to the hazardous area classification the main control panel is installed in the non-hazardous client technical area.

cGMP and SMEPAC Verified

The SMEPAC verified < 25 ng/m3 containment system conforms to cGMP standards and was fabricated in accordance with pharmaceutical standards for secondary manufacture with a fully welded design and rounded corners thus providing smooth interior surfaces.

Dec develops, designs and supplies custom-made containment system solutions for both potent and aseptic compounds that meet the growing among GMP industries.