Our Process
SERVICEE-BEAM STERILIZATION
We deliver solutions that align with our customer's needs, catering to diverse industries from food and medical devices to pharmaceuticals and cosmetics.
By adopting local and international standards such as ISO 9001 and ISO 13485 within our facility, we ensure that your products maintain their quality, reflecting the standards of your facility.
Getting started with E-Beam services is a 2-step process:
By adopting local and international standards such as ISO 9001 and ISO 13485 within our facility, we ensure that your products maintain their quality, reflecting the standards of your facility.
Getting started with E-Beam services is a 2-step process:
STEP 1PRODUCT QUALIFICATION
We conduct product qualification to identify the most efficient process parameter for delivering the optimal dosage for your specific product, ensuring the effective delivery of the required dose for sterilization in accordance with the standards and customer requirements.
PRELIMINARY CHECK
We work closely with partners to assess their product’s compatibility with E-Beam through doe validation studies to determine the min and max acceptable dose, considering initial product parameters and sterility requirements. Upon alignment, we requested samples based on the agreed specifications.
TESTING
The requested samples will undergo dose mapping to identify the optimal dose for specific products. Additional subsequent testing may be required.
ANALYSIS
The results of the dose distribution testing will be correlated with those of the additional testing to establish the optimal product-specific dose.
REPORTING
We produce an extensive report detailing testing methods and results validating product-specific process parameters for potential use in routine processing.
STEP 2ROUTINE PROCESSING
After a product has been qualified and the specific process parameter for achieving the optimal dose has been identified, it is ready for routine processing. ISI can efficiently process substantial quantities of various products within a given frame.
SCHEDULE
We Collaborate with our partners for a production timeline that meets their needs.
RECEIVE
When your qualified products reach us, they are carefully handled and stored appropriately through our automated warehouse system to maintain their quality.
IRRADIATE
We deliver a reliable irradiation process for your products using established process parameters for E-Beam irradiation.
QUALITY CONTROL
We conduct thorough quality control and assurance checks to ensure that your products receive doses per your requirements.
RELEASE
We furnish all necessary documentation and confirm consistent traceability throughout the process upon the release of your products.
Frequently Asked Questions
To save you time, here are some FAQs
How does E-beam radiation differ from other sterilization methods?
E-beam radiation offers a non-thermal, chemical-free sterilization process that is highly efficient. Unlike traditional methods, it provides precise control and does not leave residual chemicals on the treated items.
E-beam radiation offers a non-thermal, chemical-free sterilization process that is highly efficient. Unlike traditional methods, it provides precise control and does not leave residual chemicals on the treated items.
How much volume can you process?
Our process is designed to accommodate a wide range of product quantities, ranging from a single pallet to multiple truckloads, ensuring flexibility and efficiency.
What is the maximum product size you can process?
Our technology can process a maximum product size of 60cm x 40cm x 40cm. Should you have other size requirements, please do not hesitate to contact us so we can assist you further.
What industries do you serve?
We cater to a diverse array of industries, including the food sector, the health and medical device sector, commercial products, and more. Feel free to contact us if you are unsure whether your product qualifies for processing, and we will be happy to provide you with the necessary information and guidance.
What is the turn-around time?
Our service flow ensures a hassle-free experience for customers by providing a short turnaround time (from product drop-off to pick-up) within 3 working days.