PHARMACEUTICAL ENGINEERING SERVICES

For many years, GL Engineering has been providing startup, commissioning, FAT, SAT, engineering and qualification services, as well as validation documentation to the Aseptic Processing Pharmaceutical Industry.

Before

After

Design

  • The process begins with a discovery meeting to uncover any problems the customer has dealt with in their current (or new) system, what they hope to achieve with the customized products/services and how GL Engineering can help the customer accomplish their goals in the cleanest, simplest way possible.
  • Next, GL Engineering’s team will draw up the designs and concepts to solve the issues presented by the customer.
  • GL Engineering handles all aspects of developing the product / process design and implementation.

Prototyping

  • Once the designs are approved, GL Engineering will then create a prototype based on the concepts and materials chosen by the customer.

Quality Assurance

  • Prototypes are strenuously tested with fluids and simulated operations to ensure systems and components fit properly with the necessary machinery and equipment.

In-House Manufacturing

  • GL Engineering’s in-house manufacturing process allows for full discretion over all materials and methods used throughout the procedure.

Cleanroom Environment

  • GL Engineering ‘s cleanroom is designed to meet and exceeds ISO 7 (Class 10,000) specifications, providing a controlled environment with HEPA-filtered air containing a low number of particulates during the assembly and packaging process.

Packaging

  • GL Engineering’s filling needles can be packaged with a block and snap guard to preserve the integrity of the needles during transport, handling and sterilization.

Support Services

GL Engineering offers a full range of support for our products and systems including:

  • Operator training (against a structured training protocol)
  • Comparative Test Protocol
  • Full-service factory qualification and validation testing available

Consulting

  • GL Engineering offers consulting services to companies needing machinery recommendations, revamping or creating new single-use filling needle systems, needle design and product prototyping, as well as validation and qualification services for Aseptic Processes.