Contract Manufacturing

Amsino expands its capabilities as a CMO (Contract Manufacturing Outsourcing) with Liquid Contract Filling and Packaging of Aseptic Products Utilizing Blow Fill Seal (BFS) Technology.

With the acquisition of Smiths Medical ASD facility with experience of over 40 years in BFS technology Amsino is positioned to help Pharma companies to expand. The facility is FDA registered for Drug and Medical Devices and operates under cGMP guidelines. It is also 13485 registered.

Since its introduction into the North American pharmaceutical market more than 40 years ago, blow-fill-seal (BFS) aseptic processing has established itself as a highly efficient and safe system for the filling and packaging of sterile pharmaceutical liquids and other healthcare products. Lately BFS technology has been gaining increasing worldwide acceptance in the parenteral drug marketplace, replacing traditional glass vial processing and IV bags in a growing number of applications.

Our BFS manufacturing facility is proud to support our customers with:

• Development of product from pilot to commercial production
• Process development of Aseptic Blow-Fill-Seal technology for the product
• Capabilities from 0.1 mL to 1000 mL vials/bottles
• Tooling, engineering and design support
• Labeling and downstream packaging
• Documentation supporting regulatory filings
• Full commercial production
• Compounding, quality control and sterility assurance

Our proficient plastic injection molding operations accommodates a wide range of requirements.  Our efficient injection mold manufacturing procedures also include rapid prototyping before our highly experienced design team creates the mold to your designated specifications. With our skilled team managing the production process, you can expect high efficiency, quick turnaround times, and convenient turnkey manufacturing solutions. 

Our plastics manufacturing facility is proud to support multiple capabilities:

• Injection Molding

Injection Machine: 62

• Tube Extrusion

Tube Extrusion Machine: 9

• Insert Molding
• Blow Molding

Amsino offers a variety of packaging and assembly options to meet your needs. Our capabilities include:

• Form, fill, and seal machines with multiple sets of tooling, all with variable depths to accommodate the packaging of many sizes and shapes of products
• PE Pouch
• Paper Poly Pouch 
• Tyvek Poly Pouch
• Bag Sealing

For kitting and assembly services, Amsino follows GMP guidelines and offers product assembly via semi-automation or by hand.

Amsino Sterilization Services occur in our ISO-13485 certified state-of-the-art EtO sterilization facilities. These facilities have sterilization chambers and individualized preconditioning and degas rooms. Our straight-through process ensures that sterile and non-sterile products never meet. With decades of sterilization technology expertise, Amsino offers the global capacity, consistency, and redundancy to meet the exacting sterilization requirements of our customers. 

• Our Sterilization Cycles include:
  • 100% EtO
  • Nitrogen Purge
• Associated Lab Services include:
  • Tube extrusion machine: 9
• Biological Indicators
• Product sterility
• Bioburden
• Residual analysis
• Viscosity Testing
• PH testing

Amsino serves as a partner to many healthcare companies seeking to create lubricious surfaces on medical devices. Amsino provides both Hydrophilic and Antimicrobial coating services. Currently both of our coating technology is used on Foley catheters, which increases patient comfort and wellness.

Amsino designs, develops, and validates contracted products by leveraging its deep expertise in R&D for the medical device industry, while meeting regulatory requirements for multiple geographies. Our R&D team can assist you with:

• Concept assessment (IP/Design/Realization)
• Design (2D/3D)
• Rapid prototyping (In house 3D printer)
• DFMEA
• Fast tooling development 
• Self-made equipment capability
• Design validation (Product/Process)

Amsino is a contract manufacturer where we produce the medical device to your specification and with your label. You as the customer own the regulatory approval. Amsino has a dedicated team that can transfer your plant, product line or tooling to our facilities, making your products from plastic resin to finished sterile product with your label. Amsino manufacturing plants are ISO certified, FDA registered and audited to ensure ongoing compliance with QSR regulations. We offer efficient and low-cost product development including R&D, engineering, product design, prototyping, validations, and documentation.

Our cost efficient, vertically integrated manufacturing capabilities include in-house sterilization, regulatory & quality support, marketing support, and a professional management team skilled in all areas of the transfer process.

Amsino has transferred entire product lines from Europe, North America, and Australia into our China facilities. We can make this process a systematic transition.

Outsourcing Capabilities

• Project Gate Process
• Transfer Process
• Program Management
• Product Development
• Extended Arm for Future Engineering
• Platform for Emerging Markets