Case Study：Powder and Solids Equipment - Renovation Programme for UV Lamp Transfer Windows and Dispensing, Feeding RABS

Are you ready to elevate your powder and solid systems to meet the latest regulatory standards?

Our comprehensive services include Powdered Solids Facility Repair, Renovation, and Validation, ensuring compliance with GMP and CSV (Computerized System Validation) requirements. Contact us to learn how AUSTAR Technical Services can support your powder and solid systems with customized renovation solutions for optimal performance, durability, and reliability.

The client is a global healthcare company with an extensive product range spanning over ten therapeutic areas, encompassing 1,400 compounds and biological products. AUSTAR has maintained a close partnership with them for many years.

Client Requirements：

• UV lamp transfer windows without EFUs (Fan Filter Units) cannot achieve a Class A environment.

• Lack of audit trail functionality and batch transfer records fails to meet Computerized System Validation (CSV) requirements.

• The dispensing and feeding RABS lack in-line air velocity detection equipment.

• Poor touch screen placement and insufficient internal lighting hinder operation.

• Manually pushing aluminum into drums risks generating aluminum shavings that could compromise the environment.

Our Solutions：

• Construct an airtight self-cleaning transfer window with a double-sided return air corridor: the transfer door employs an air-sealed structure to achieve a Class A environment.

• Install a 9-inch touch screen to enable audit trail functionality, generating printable reports for each batch transfer record.

• Equip the interior with an on-line anemometer for real-time wind speed monitoring.

• Adjust the layout by relocating the touch screen to the side of the new RABS section and adding LED lighting for improved operational convenience.

• Include a barrel management section outside, where aluminum barrels are placed for automatic transfer into the oRABS after the self-cleaning cycle, minimizing contamination risks.

Before VS After: Let's check out AUSTAR's renovation solution for powder and solid system!

Renovation Solutions from AUSTAR for Powder and Solid Systems

Client Benefits:

• The space now meets Class A standards and complies with GMP requirements.

• Clear sight-lines and a rational layout enhance on-site operations.

• The implementation of audit trail functionality and batch transfer record reporting fulfills CSV requirements.

• Ensured cleanliness and safety of the aseptic operating environment, improving the accuracy of aseptic inspection test results.