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Package Design, Testing and Prototyping:
ACI is your
package designer. When combined with our state of the art
package design, prototyping, package testing and material selection expertise, the obvious conclusion is
that ACI can provide the
complete package design solutions that meet you and your customers
and strict product and regulatory requirements.
For our medical
device packaging customers please note:
Virtually all
products manufactured by Medical Device Companies are packaged
in:
1. Four side seal pouch / sachet pack; (2 dimensional) or
2. Thermoformed pouch / formed tray (3 dimensional) including rigid and
flexible package solutions
ACI has the expertise
for providing these packages in a safe, effective and
compliant end product format,
including child resistant packaging.
If you find your self struggling with the regulatory
aspects of package design, ACI offers:
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Design Control Procedures:
We plan and design your packaging according to your
specifications and in compliance with EN/ISO 13485
and FDA Guidelines.
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Bio-Compatibility Study
Protocols:
We help you plan and design your packaging in compliance
with EN/ISO 10993-1 Guidelines.
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Shelf Life/Aging Studies:
We help you plan and design your packaging in compliance
with EN/ISO Guidelines.
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Child Resistant Packaging
Design:
We help you design your packaging in compliance with child
resistance packaging guidelines.
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Sterilization Validation
Protocols:
We will work with your company to
determine your sterilization validation needs and
requirements and help you maintain regulatory compliance.
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Package Testing
Protocols:
We can
determine your package testing needs and
requirements in compliance with ASTM and ISO/EN Guidelines
to help you maintain regulatory compliance.
Our contract packaging solutions are compliant to FDA and ISO/EN 13485 and
can help provide:
- Safe, effective and compliant packaging
- Significantly increased speed to market
- Competitive raw material cost and material utilization
- Fewer planning or communication issues with multiple
suppliers available
- Accountability and excellence in SPC and Quality Control
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