Medical devices, aimed to contact the patient body’s internal environment must be free of any contamination, in accordance with the regulatory authorities and standards.
In order to reach acceptable levels of sterility of a packed product throughout its declared shelf life, the product will undergo the following process:
Assembly, cleaning and packing in a clean room environment
Sterilization process design and validation
Packaging validation including accelerated aging
Taryag provides A-Z services covering all stages of a product sterilization process,including development of a sterilization validation protocol,design and manufacture of Process Challenge Devices (PCDs), supply of biological indicators (BI), perform of sterilization, Lab samples delivery etc.
ISO13485 and ISO 11135 Certified, Taryag-sterilization is a home for designers and manufacturers wishing to implement product-oriented sterilization validation processes. Taryag operates small and medium-volume (250 and 10000 liters) EO sterilization chambers and provides complete sterilization validation process, single-lot releases and routine sterilization services for validated products and healthcare service providers. Routine sterilizations can be completed within 24 hours from delivery. We excel at sterilization process development, starting from cycle design based on product-unique characteristics through cycle optimization and protocol generation.
The sterilization validation process is preformed to validate that the sterilization process parameters are sufficient to achieve an acceptable sterility level to be applied during routine sterilization lots. Based on the device’s characteristics, development of a product-specific sterilization protocol requires experimentation, including number of iterations to determine the optimal sterilization process parameters. To maximize the process’s effectiveness, the medical device characteristics will be introduced to Taryag team. We believe that direct and frequent interaction with our customers improves our team’s knowledge and ability to produce the best possible parameters, reducing the physical performance qualification (PPQ) process length to a single week.
The biological and chemical tests required as part of the validation process (“The Over Kill Approach”) can be executed by TARYAG LABS certified laboratories.
A single lot release is a minimization of the sterilization validation process designed to provide a solution for those wish to sterilize a specific product lot, in example products that will be used for clinical trial. Although the process is validated, it is validated only for the specific lot and cannot be repeated as a routine lot.
As adjacent interlinked process to sterilization validation, Taryag is certified and provides a complete solution for packaging validation. Shelf-life period is simulated at shorter duration than real-time by accelerated aging. The package “age” is simulated by placing it at a temperature and moisture-controlled incubator for a precalculated period. Taryag operates multiple temperature-controlled incubators at different volumes, according to the product’s characteristics. The aging process conditions are monitored, recorded and analyzed in order toprove conformance with the predetermined values.
Technical tests are applied on package samples right after sterilization and following the simulated aging period:
Visual Inspection by white and UV light is preformed to examine the package’s integrity, to identify locations that are prone to failure and to
Dye Penetration test, or "eye dropper method" is used to verify package’s integrity along the seals formed between the transparent material and a porous sheet material (i.e. pouches). The method can detect minute channels that cannot be identified otherwise.
Pouch Seal Strength Test examines the mechanical strength of the package by means of applying a controlled and a measurable stress upon the package’s seals. This process aims to assess the packaging processes’ ability to produce consistent seals.
determines the package’s performance as sterility barrier to resist the penetration of air through the porous material by means of immersion or by internal pressurization.
Due to our team’s knowledge and experience, we now offer our customers with package design services. Designers and start-up companies can utilize our capabilities and find a collection of packaging solutions starting from variety of pouche sizes and designs, to small-scale production of pouch cards and blister packs.
Counseling and Solutions
Ingenuity, Experience and Professionalism are among Taryag’s qualities that provide us with excellent counseling services, accompanying every stage in the development of a sterile product: design of package, the sterilization process, lab testing etc.
We provide our customers with solutions for various problem along the way, contributing our knowledge aiding in many aspects of the start-up and bio-tech practice.