What is EtO Sterilisation?
EtO sterilisation is a low-temperature (~45°C) process that uses Ethylene oxide gas to eliminate/reduce the level of microbiological contaminants. EtO gas is used in combination with inert gases.
What kind of products can be treated by EtO?
Ethylene oxide (EtO) gas is widely used to sterilise materials and products that would be damaged by methods involving heat, moisture or radiation. EtO can be used to eliminate/reduce the microbial population on products falling under the following industries:
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- Disposable Medical Devices (Syringes, surgical gloves, surgical gowns, etc.)
- Packaging Components (Container closure systems, packaging material, etc.)
- Agriculture Produce (Whole & ground spices, dehydrated veggies, etc.)
- Pharmaceutical Raw Material & formulations (API, ointments, excipients, etc.)
- Cosmetic Raw Material & finished products (Talc, starch, beauty products, etc.)
- Herbal extracts & formulations (Dehydrated herbs, ayurvedic products, etc.)
What is the shelf life of the EtO sterilised products?
Shelf life of the product is assured as long as the integrity of the primary package is not compromised.
What are the acceptable limits for EtO residue in treated products?
In case of medical devices, the acceptable limits are as per the specifications provided in the standard ISO 10993-7.
Whereas for spices and dried vegetables, ASTA (US) has specified the limits of 7 ppm for Ethylene oxide and 940 ppm for Ethylene chlorohydrin.
What is the primary/secondary packaging compatible with EtO treatment?
Products requiring treatment should be packed / wrapped individually / collectively in poly bags or medical grade paper pouch and then into cartons or poly-lined bags. EtO penetrates all the above packaging and renders disposable medical products sterile and in the case of bulk products lowers its bio-burden to within acceptable limits.
All polyester and metallic based packaging are not compatible with EtO.
What information is required to get a quotation for EtO process?
MICROTROL requires the following information:
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- Product
- Cartons/containers/bags dimensions
- Gross weight
- Packaging details (primary and/or secondary)
What is Gamma radiation?
Gamma rays are a type of electromagnetic radiation. Gamma radiation is the process of subjecting any product to ionising radiation (Cobalt-60) to achieve the following objectives such as:
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- Sterilisation of the product (Medical devises / disposables, Pharmaceutical raw material etc.)
- Reduction of Pathogens (Spices, Herbs, Animal Feed, Marine Products ready to cook/eat foods, etc)
- Disinfestation for hygienisation and quarantine control purposes (Cereals, pulses, fruits, etc.)
- Sprout Inhibition (Potatoes, Onion, Garlic, etc.)
- Vulcanization (for production of Radiation Vulcanized Rubber Latex)
- Cross linking of Polymers to improve mechanical properties
Are Gamma irradiated products harmful to use/consume?
No, the process is regulated by various national and international standards/guidelines (ISO, FSSAI, etc.). There are absolutely no harmful by-products generated by irradiation. The method is safe and clean with no chemical residues.
What are the standards used to validate a healthcare product using Gamma radiation process?
ISO 11137-1 & 2
What products cannot be irradiated?
The following products (not exhaustive) cannot be irradiated:
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- Foods such as dairy, products containing sugar and eggs cannot be irradiated as it causes changes in flavour or texture
- Polymers such as polypropylene, polystyrene cannot be subjected to high doses
Can small quantities of products be irradiated?
Yes. Product samples can also be irradiated.
Does the product need to be opened for Gamma irradiation?
No, Gamma rays are highly penetrating and thus can be processed even if your product is completely sealed.
What information is required to get a quotation for Gamma radiation process?
MICROTROL requires the following info:
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- Product
- Cartons/containers/bags dimensions
- Gross weight
- Desired minimum dose
What are the documents required to be sent along with the product for Gamma radiation process?
What is the primary/secondary packaging compatible with irradiation treatment?
Products requiring treatment should be packed in cartons, paper/poly bags, HDPE drums or custom-made packages. They are processed in Aluminium tote boxes sized 600 mm (L) x 450 mm (W) x 1100 mm (H).
How is the Gamma radiation dose measured?
Gamma radiation dose is measured using a device called ‘Dosimeter’. These dosimeters are strategically placed around the product. The dosimeters are calibrated and traceable as per national/international standards.
What is the shelf life of a Gamma sterilised product?
Shelf life of the product is assured as long as the integrity of the primary package is not compromised.
Does my product get radioactive after Gamma treatment?
No, your product will not become radioactive by exposure to Gamma rays.
Can a product be re-sterilised using Gamma radiation?
Generally, irradiated products are not re-sterilised. However, if the product can withstand a higher irradiation dose, then it could be re-treated.
Do you provide a sterility certificate for products treated with Gamma radiation?
MICROTROL does not provide a sterility certificate, however, we issue a Gamma Processing Certificate with every consignment indicating the minimum & maximum dose imparted to the product.
Can a product be processed with gamma radiation in controlled temperature/special conditions?
Yes, please contact MICROTROL for more information.
What is Steam Treatment Service?
The Steam Treatment uses saturated steam as the medium to reduce the microbial load in spices, herbs and dehydrated products with minimum impact on its organoleptic properties.
This is a chemical free process which is ideal to treat all organic produce.
What are the categories of products that can be treated with Steam Treatment?
MICROTROL can treat spices (whole/cut/milled/ground), herbal products (whole/cut/milled/ground) and medical disposables with Steam Treatment.
Is there any process loss post Steam Treatment?
There could be some process loss due to handling.
Is there any change in product properties post treatment?
Since Natural Pasteurisation Process treatment involves subjecting the product to high temperatures (>100°C), slight changes in physical product characteristics maybe observed. Please contact MICROTROL for more information.
Is the process validated?
The process is validated using a Salmonella surrogate (Enterococcus faecium NCIMB 2699) to demonstrate 5 log reduction.
Do you have a testing facility?
MICROTROL has in-house microbiology labs at all our NPP facilities that carry out microbial and physical tests and issues steam treatment certificates.
How many different processes do you have in Steam Treatment?
Based on different product and packing applications, MICROTROL has designed different processes which are listed below:
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- Pre-packed batch process for whole/seed spices
- Fluidised batch process for whole/seed spices
- Batch process for herbal products
- Continuous process for Ground Spices and Psyllium products
What is the primary/secondary packaging compatible with Steam Treatment?
For pre-packed batch process for whole/seeds spices, 4 ply Kraft paper bags (80 GSM).
For all other processes, packaging is stripped open/untied, weighed and then loaded into the steriliser. Customers are expected to provide necessary packing material to pack products post treatment, as per their requirement.
MICROTROL provides repacking services only on 15 kg to 50 kg bags.
Do you have metal detectors?
Yes, MICROTROL has metal detectors installed in all steam treatment facilities.