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Customer

Undisclosed pharma industry Italy

Customer Challenge

A major pharmaceutical company required new customized filling system to handle filling of inhaler powders within required constraints.

Our client was looking for customized pharmaceutical filling equipment able to guarantee containment during the manufacturing process to fill special inhaler powder into a handheld dry powder inhaler. The inhaler delivers therapeutic formulations to the lungs for the treatment of Asthma and Chronic Obstructive Pulmonary disease. The new filling equipment needs to accommodate a complex dosing system provided by the client and fit all the sub-equipment needed for the process. The client wanted a flexible solution, adaptable to ongoing requests during project development, and turned to Comecer for a complete customized solution, as they had not found any on the market.

Comecer Approach

Comecer developed an integrated filling line inside a totally closed environment, i.e. an isolator, where the entire process is performed.

By providing a complete isolator around the filling machine and with the perfect integration between them, the requirements for containment and as well the potential risk of powder explosion are addressed. The required containment level is OEB 5 (from 0.01 to 1.00 µg/m³). The powder filling dosing range into the final device is from 0.5 g to 4.0 g.

Comecer used external consultants to analyze unusual aspects that arose during the design stages, reviewing possible solutions with the client to understand step by step how to move forward.

Comecer completely customized the isolator and filling machine to handle special device filling.

Solution Highlights

The developed equipment is a semi-automatic robotic machine fully integrated inside an isolator and requires just one operator to run. The isolator allows a totally closed process, and the machine under the isolator performs these steps:

• Load the device
• Open the device cover
• Record the weight before filling
• Fill the powder into the device within the dosing head
• Record the weight after filling (gross)
• Cap the device
• Check the cap
• Unload the filled and capped devices

The tested and validated equipment is currently installed at the client site.