GMP Ophthalmic Filling Room for CMO

Investing in a brand-new Ophthalmic space in Canada means investing in a new cleanroom area. This contract manufacturing organization (CMO) needed a GMP ophthalmic filling room. The cleanroom space needs to respect the good manufacturing practices (GMP) requirements to produce sterile ophthalmic products.

The new 600 ft² ophthalmic filling room is a grade B cleanroom, which equals an ISO 5 at rest and an ISO 7 in operation.

Here is the summary’s project:

  • Industry: Pharma / Biopharma / CMO
  • Location: Kirkland, Canada
  • Size of the cleanroom: 600 ft²
  • Cleanroom class: GMP Grade B (ISO 5 at rest / ISO 7 in operation)
  • Removable wall partition for introducing new, big equipment
  • GMP ophthalmic filling room
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Custom Cleanroom Solutions to Overcome Challenges 

This integrated CDMO specializes in manufacturing parenteral preparations (sterile) for ophthalmic products, ointments, creams, and gels. Upscaling their production capacity meant two things: a new cleanroom and new equipment were needed.

This client bought a new high-speed filling machine that will be delivered in a year. However, the new device is quite massive, and they didn’t want to disrupt the production process for more than a day to diminish the cost of introducing that new machine.

Mecart came with a custom design for their new cleanroom that will allow an effortless entrance and installation of the machine. In addition, the cleanroom has been designed and built with 2 removable wall partitions to solve this client’s problem.

When operational, the cleanroom environment will be providing:

  • Four sterile filling suites for quick change-overs and flexibility
  • Fully automated CIP / SIP
  • Aseptic filling and terminal sterilization

An Ophthalmic Filling Cleanroom for Providing a Sterile Environment

The process of ophthalmic manufacturing needs to be overseen and controlled carefully to ensure the safety and sterility of the ophthalmic solutions, preservative-free eye drops, and sterile ointments.

Various infections and diseases of the eye’s mucous membranes can occur if a foreign element or body find its way into any ophthalmic product. In addition, cross-contamination could cause severe health issues, as the eyes are directly related to the nervous system.

That’s why the ophthalmic filling requires to take place in a clean room environment under the current good manufacturing practices guidelines (cGMP).

In the cleanroom area, multiple types of equipment are necessary. the production activities for ophthalmic preparations require monitoring devices for in-process controls. Ophthalmic products need to be filled with water for injection (WFI).  And also, a grade A vertical laminar flow hood (LAF) is necessary for the filling room.

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