QUALITY IN EVERY DETAIL
OEM Replacements For All Fill-Finish Brands
We offer 21 standard sizes for the world’s most popular fill-finish machinery.
Eliminate Issues with Reusable Components
No more damaged needles after cleaning and sterilization.
Eliminate Cross Contamination
Utilize new components for each batch.
ELIMINATE CLEANING & VALIDATION
We believe that the future of liquid packaging lies in the flexibility and efficiency of single-use technology, improving operations in the following ways:
Single-use technology can significantly increase productivity by eliminating complex and time consuming steps like cleaning and validation. Pre-sterilized single-use components no longer add to the bottleneck at the autoclave and can be passed directly into the filling suite to be utilized.
Additionally, the simple disposal of single-use components immediately after their utilization significantly improves line process and changeover times.
Durable components must be cleaned and sterilized prior to usage. In the event there is a last minute change of schedule, you may be left in a situation where you do not have the right components ready for a fill.
Single-use components are multi-bagged and can be provided gamma-sterilized, ready to use. All that is needed to address a changeover is to swap components from material control. Eliminate lost revenue due to scheduling issues.
Realize direct savings related to material and labor costs. Costs for water, chemicals and cleaning validation are significantly reduced. Additionally, less demand is placed on water systems, leading to prolonged operating life and further reduction in total cost of operations.
The storage of reusable pumps and needles takes up valuable space that can be dedicated to production.
Single-use components can be purchased on a schedule that matches their usage, significantly reducing inventory-related tax burden.
Biopharmaceutical production facilities utilizing single-use technologies reduce costs related to the processing and disposal of chemical-laden rinsate created during the cleaning and sterilization process.
Not only is there a strong financial incentive to do this, but also an environmental imperative to reduce the carbon footprint of production plants.
QUALITY IN EVERY STEP
Manufacturing & Packaging
OneShot™ filler needles undergo a strict quality review of all manufacturing and packaging documentation prior to shipment:
Clean Room Inspection and Bagging
All needles are cleaned, assembled, inspected and packaged in an ISO 7 clean room, utilizing 4mil thick clean room quality bags.
Full Quality Inspection
Quality reviews each order prior to batch release.
Detailed Product Label
Including part-number, job number, date of manufacture and expiry or use-by date.
How To Order
We use a specific protocol to provide the utmost transparency and service to our customers at every step of the ordering process:
A quote for your item will be provided, either with the requested quantity or standard price breaks.
We ask that all orders submitted to our sales team include part-number, item quantity and per-item price.
After receipt of PO, an acknowledgement will be sent by our sales team within 48 hours to verify order info, including expected ship date.
Once your PO has been acknowledged, our production team will begin working on your order.
Once your items are completed, they will be inspected, bagged and shipped per our QMS. Certificate of compliance accompanies each order.
QUALITY IN EVERY ORDER
Each Batch Release Includes
Overlook C of C
The full manufacturing package, including production logs and raw material certs, is maintained by quality for 5 years.
Detailed Packing Slip
A detailed packing slip provides all relevant order info to be easily handled by your receiving department.
Gamma Certs and Indicators
Gamma-sterilized items include certs of process and color-changing gamma indicators on all labels.
Gamma-sterilized items are validated to a 30-month shelf life from the date of manufacture.
All non-sterile items are double-bagged and gamma-sterilized items are triple-bagged in clean room quality bags.
Electronic Job Records
All job records are scanned to multiple secure locations and are available for reference upon request.
Request a Quote
Please use this form to request pricing. Our sales team will get in touch with you as soon as possible.