Esco Pharma USA Successfully Commissions a Filling Line Isolator Project
The manufacture of sterile pharmaceuticals requires advanced technologies like filling line machines to ensure compliance with stringent manufacturing guidelines.
Pharmaceutical filling line streamlines the manufacturing process of medicines. It is capable of expediting the filling of hundreds of vials, ampules, or pre-filled syringes per minute of production while preventing product loss and ensuring consistent volume of product. It can also facilitate continuous operation in meeting the output demands of production. A filling line equipment can be a fully automated or semi-automated system that offers sterility control for critical operations. This is now becoming the standard of sterile pharmaceutical manufacturing.
Esco Pharma designs and manufactures isolation containment systems that are built around the design of the filling line equipment and customizes it to meet individual client requirements. Filling line isolators commonly enclose the filling, stoppering, and capping processes of a filling line machine. The system provides an ISO Class 5/Grade A environment and integrated hydrogen peroxide decontamination to ensure the sterility of the area and to meet the stringent demands of sterile production. Filling line system projects usually have a duration of 8 to 14 months depending on the complexity of the design and the customizations that are needed to be done.
This month, Esco Technologies Inc. (Esco Pharma USA) finished the commissioning of its project for filling line isolators and open restricted access barrier system (oRABS) for a pharmaceutical manufacturing company in the USA.
The complete equipment contains the following components:
- an oRABS for the automatic bag opening process,
- a 2-glove Isolator for the automatic tub opening process,
- a 4-glove Isolator for the automated robotic filling and closing, and
an oRABS for the vial sealing module
The filling line system was designed with an entry oRABS for bag removal, connected to an isolator for tub opening, and then an isolator for the automated filling and closing of the vials. Lastly, it connects to an exit oRABS where the capping process is carried out.
The isolators and oRABS systems were designed to create a continuous environment that will achieve the required operating parameters of the filling line machine. It is designed to operate in a positive pressure relative to the ambient environment, with a suitable pressure cascade between different modules. It also operates in Grade A/ISO Class 5 laminar airflow conditions.
The two units of isolators are double-wall designed with inlet and exhaust ducted out of the room to remote HVAC skids. Both are capable of temperature control with cooling mechanisms. The tub opening isolator is equipped with one rapid transfer port (RTP) for waste removal. While the fill close module isolator is equipped with two RTPs, one is for liquid transfer to the pump and the other is for charging of the stoppers.
These isolators are also equipped with the BioVap™ biodecontamination system with onboard hydrogen peroxide sensors and room sensors. It is designed with remote skids for exhaust with double-stage catalytic converters which enables the system to exhaust air back to the building after the biodecontamination process.
The equipment and its control system were designed and constructed following cGMP and GAMP 5 guidelines in addition to industrial equipment directives.
Filling line isolators are designed to incorporate third-party filling line equipment. To ensure the delivery of quality products, Esco Pharma works hand in hand with partners from leading filling line manufacturers. While the process of building a filling line isolator system requires extensive planning, Esco Pharma, amplified with its experience, is consistent in bringing about solutions for worthwhile challenges.
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