The multi-purpose isolator is designed for use in a pharmaceutical manufacturing area for the contamination-free handling of highly potent active pharmaceutical ingredients (APIs).
The containment system is developed with Dec’s unique ergonomic package to ensure ease of use.
On top of this unique program methodology (developed by Dec), the containment system offers an ultra-safe working environment ensuring there is little chance of API egress.
Dec’s own designed seal system governed by PLC with glove in-rush guarantees safety of product from the surrounding area.
This system incorporates Dec’s enhanced safety system developed from their experience from real world installations operating around the globe.
This particular isolator consists of three chambers, which are used for weighing and filling operations of potent active ingredients, final and intermediate products, verification of product quality and sampling in a completely closed working area.
The system meets OEB5 requirements (maximum workplace concentration OEL
0.4 µg / m³ per 8 hours of operation).
• Provide a safe barrier between the operator and the active drug substance to provide both operator and product protection.
• System to be designed for multi-product use for OEB5 category potent compounds.
• Isolator able to transfer bagged API into the isolator via a transfer interlocked passbox.
• Passbox is able to dock various size drums onto the rear of the chamber using dummy drum arrangement.
• Lower drum chamber capable of lifting and docking various size drums onto the underside of the upper dispensing chamber to enable sampling and dispensing to take place.
• RTP transfer provided for all product transfer from the dispensing upper chamber.
• To enable the process plant to be Cleaned In Place where physically possible.
• The external of the isolator is designed to be operated in a non ATEX safe area and the internal is designed to operate within a Zone 21 2D hazardous environment.
• The air change rates in once-through mode to exceed 20 v/h.
• To allow sampling of API within the upper dispensing chamber and to provide a contained transfer method from the isolator for samples and dispensed active materials
• To dispense API’s to a predetermined weigh and accuracy
• Isolator exhaust gas from isolator to be passed through an activated carbon filter to remove solvent vapor odors prior to exhausting the air through a pipe that goes outside the building
Due to the installation of the isolator into basement of the building and the height and length restriction when bringing the isolator into the building and down into the basement, the isolator will be constructed so that all three chambers are connected via flange bolting and sealed to the required containment.
Chamber 1 (Upper-Dispensing):- Is designed as the primary level of containment and shall include a flush mounted bench scale in 316 stainless steel with a range of 0 – 15,000g and an accuracy 0.1g which will be recessed into the isolator work surface.
For ease of operation the weigh scale display is mounted internally into a stainless steel panel which is connected to the isolator ceiling via a tri-clamp connection. A flange connection is provided in the work surface of the chamber to interconnect Chamber 1 (upper dispensing) to Chamber 3 (lower drum docking). A removable internal transfer door is provided and equipped with an interlocked inflatable seal and bag clamping flange. A bag protection sleeve is provided which is used to protect the internal product bag during the dispensing process.
To aid manual handling of a part filled bag from the drum docked in the underside of Chamber 1, a product bag lift system is provided in the chamber and mounted directly above the internal transfer door. This will consist of a pneumatic cylinder which will be mounted directly to the ceiling of the chamber to the required containment. When the lift system is not required the cylinder will be fully retracted onto the ceiling.
To enable the contained removal of the final dispensed product and the safe and contained removal of waste materials a RTP Transfer System is provided in the right hand lateral wall.
After the operation, product and wastes are discharged without contamination by an RTP transfer system in the right side wall of the chamber.
Chamber 2 (Upper – Drum Airlock) This chamber is designed to operate as a transfer airlock used for the clean and contained transfer of sealed bagged powder max 20Kg from a drum which is docked onto the rear of the isolator.
The chamber shall include a rear drum docking system with interlocked internal transfer door mounted onto the rear wall of the chamber and equipped with an external drum tipper.
An external transfer door is provided on the left lateral side for the transfer of small containers of API, packaging materials, sample jars etc. into the isolator.
The door is equipped with an interlocked inflatable seal, which is interlocked with the internal transfer door. The drum loading chamber has a number of pneumatic door interlocks that are sequentially controlled via the control system.
A flanged connection is provided on the right lateral side of the chamber to interconnect Chamber 2 (drum docking) to Chamber 1 (upper dispensing). An internal interlocked transfer door is provided with inflatable seal system.
The pneumatic door locks are controlled sequentially.
Chamber 3 (Lower drum docking): The lower chamber is designed to enable the docking of larger drums up to 50Kg onto the underside of chamber 1 to permit the manual dispensing of API from the drum. This chamber is designed as a secondary containment.
The chamber shall include a pneumatic drum lift/docking system to allow dispensing from within Chamber 1 (main chamber). The chamber is accessed via hinged glove port visor door to the rear of the isolator. An additional fixed glove port visor is provided at the front of the isolator to allow full access for the wipe down of the drum exterior before exiting the chamber. The drum in the raised and dock position will protrude into the chamber 1 to aid the manual dispensing operation.
Chambers 1 and 2 are equipped with rotating spray nozzles and all chambers with a low velocity hand held spray gun designed for gross decontamination. The work surface of each chamber is sloped to a single drainage point where the liquid is drained through a manually operated stainless steel sanitary diaphragm valve.