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Cleanroom Packaging

FTI Cleanroom
FTI’s Class 7 cleanroom is a hardwall, reconfigurable, scalable design.

Customized Sterile Barrier Packaging of Our Fiber Optic Components for Demanding Applications

Sterile Containment
 Personnel access is strictly controlled. Those certified to enter the room pass through an outer gowning area where they dress in PPE required to keep the room within acceptable levels of air quality.

FTI’s packaging cleanroom represents state-of-the-art design and construction relative to a Class 7 Cleanroom facility.  The room is a hardwall, reconfigurable design, intended to be upsized or adapted quickly should demand or component quantities require it.

The cleanroom was designed to support customers in any market who require sterile barrier packaging, with or without sterilization coordinated services.

Belco tray and pouch sealers repeatedly produce dependable sterile barrier containers assuring contamination and FOD free components from containment through transportation, receiving and inventory storage until the component is ready for integration or final use.

Our sterile barriers are suitable for Radiation (gamma, x-ray, e-beam) and EO sterilization; a coordinating service offered as an outsourced option when required.

Radiation-and-Gas-Sterilization
Packages along with their contents are approved for radiation and gas sterilization.

Currently, FTI has a validated process for sealing an 8” x 16” peel pouch, as well as 17” x 8.5” x 2”, and a 15” x 7” x 2” PET-G trays w/ Tyvek lids, suitable for packaging most fiberoptic cables and lighting accessories.

All new package configurations go through independent lab validation for sterilization, bioburden and seal effectiveness.

Our seal integrity and visual aesthetics have been rigorously qualified and routinely monitored with each lot produced to maintain integrity. Products using our established packaging may also be adopted, with 3rd party testing, that rigorously demonstrate our packaging withstands the hazards of transportation, receiving and inventory storage, until the device is ready for integration or final use.  FTI will also work with you to oversee 3rd party accelerated aging and transportation testing for new material or packaging design configurations! [ZM1] The room utilizes continuous monitored, laminar flow, positive pressure air through high efficiency particulate air (HEPA) filters to remove airborne particulate as small as .3 microns.  

To assure seal consistency, optimal levels of temperature and humidity will be maintained through a dedicated, room controlled HVAC system, even though the cleanroom itself is already contained within a climate controlled facility.

Fiber Optics Sealing
Medical Packaging Sealer
FTI has a validated process for sealing 17” x 8.5” x 2”, and a 15” x 7” x 2” PET-G trays w/ Tyvek lids, as well as an 8” x 16” peel pouch, suitable for packaging most fiberoptic cables, surgical and lighting accessories
Since its construction, the cleanroom has met the requirements of ISO14644, FDA regulations, and Good Manufacturing Practices (GMP), and certified for use by 3rd party service providers who conduct regular re-certification inspections. The packaging process itself is under configuration control, tightly monitored, and validated in compliance with ISO 11607-2 Sealing Process Validation. Multiple in-process inspections, governed by AQL, assures consistency in process and results.
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