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Stainless Steel Services -

Filling needles and nozzles that have braised or press fit components are inherently poor choices for ampoule, vial and syringe packaging. Braising material is porous, allowing for cross contamination. Press fit components have spaces, allowing for entrapment and separation at the joints. Additionally, OEM needles that have interior cross drilled intersecting holes provide ample sites to collect product, microbial, chemical and detergent residues and can only be cleaned using flushing methods.

According to FDA's Guide to Inspection of Validation of Cleaning Processes, "this procedure does not physically remove residues, may require a significant volume of solvent, may leave residues in corners, voids and threads and does not provide information regarding these areas that are distinctly more difficult to clean."

Our Solution

Overlook Industries, Inc. works diligently to redesign these problem needles and nozzles and provide its customers with a state of the art sanitary design that will facilitate the cleaning validation procedure. By designing and producing components based on Continuous Tube Construction, we provide you with smooth interiors to swab, or in the case of rinse sampling procedures, the confidence that there are no sharp corners, voids or areas for residue to collect.

Benefits:

• Reduce validation costs by providing smooth void free interior and exterior surfaces.
• Enable swabbing technique by removing multiple joints and intersecting interiors.
• Expedite cleaning and sterilization processes of rinse sampling method based on Continuous Tube Construction.
• Reduce production delays by providing components that require less time to clean and sterilize.

Additional Procedures:

Electropolishing - Complementary to our superior design and construction, Overlook Industries runs every part through an electropolishing process, greatly reducing the opportunity for residue to collect within surface discrepancies.

Custom Laser Marking - The ultimate in traceability, laser engraving will produce a permanent, customizable identification of every component.

Single-Use Services -

Overlook single-use products undergo comprehensive processing in order to guarantee compliance, cleanliness and sterility, allowing our customers to rest assured that all components are ready for aseptic use upon recieval.

All Overlook single-use products can undergo the following pre-delivery procedures, per customer requirements:

• Heated ultrasonic passivation
• Particulate cleaning with hot WFI in Class 1,000 clean room
• Vacuum autoclaving for dryness
• Sterile packaging (multi-bagged)
• Gamma sterilization
• Third party testing

Application Development -

Overlook is highly focused on providing solutions to problems that work properly and flawlessly from the get-go. We work closely with our customers to develop components and assemblies that fulfill their needs at a competitive price.

By discussing the customer's pump and tubing type along with the tip geometries and coatings that Overlook most commonly utilizes, a good deal of progress can be made in a short period of time regarding the appropriate needle design for a specific application. The following list includes the most common considerations that are involved in Overlook's design process:

• Pump types
• Basket tip design (for foaming and splashing)
• Showerhead design (for foaming and splashing in high volume applications)
• Teflon coating (for wicking of product on OD and tip of filler needle)
• Co-axial (co-ax) filler needles (for oxygen-sensitive products)
• "Rainbow" coating (for metal-sensitive products)

Clean Room Services -

Overlook has recently completed construction of a clean room that is to be validated for class 10,000 operation. The primary function of the clean room is to provide a controlled assembly space for components in Overlook's single-use product line, including OneShot™ single-use filler needles and Freedom Filler™ kits. The clean room is available for contract assembly work as well.