Gamma Radiation Sterilization
Gamma Radiation Sterilization
Gamma Radiation Sterilization Almost all medical products that are covered in schedule C and C1 are commonly sterilized by gamma radiation. An indicative list of these products is given below:-
❖ Surgical Disposables :- Surgical Sutures, Bandages, Dressings, Gauge pads, Nappies, Delivery Kits etc, which are made of Cotton Wool and Gauge.
❖ Metallic Products:- Surgical Blades, Needles, Implants, Aluminum Caps, Containers etc.
❖ Plastic And Rubber Items:- Petri-dish, Centrifuge Tube, Blood Collection Sets, Scalp Vein Sets, Shunt Valves, Rubber Gloves, Contraceptive Devices, Gowns, Wraps Covers, Sheets, etc.
❖ Pharmaceuticals:- Silver Sulphadiazene Cream, Gelatin Capsule, Bentonite Charcoal, Ergot Powder, Absorbable gelatin, Ophthalmic preparations in paraffin base and oil base, Skin Ointment in Polyethylene glycol base.
❖ Ayurvedic:- Raw Materials, Herbs, Medicines, Granules.
❖ Spices:- Whole and in Processed form
Requirements of The Products For Irradiation
- ➮ Packing
- ➮ Weight of box
- ➮
- ➮ Documents
- ➮ Charges
- ➮ Regulatory consent for drug items
- ➮ To be packed in standard 5 ply corrugated card board cartons of outer dimension: 59cm L x 43cm x 33cm. (H)
- ➮ For 25 kGy irradiation dose, (usually health care products), the maximum weight of the box should not exceed 15.0 kg
- ➮ For 15 kGy irradiation dose, (usually herbal and ayurvedic products) the maximum weight of the box can be upto 30.0 kg
- ➮ The consignment should be submitted with a covering order specifying the product detail and irradiation dose* requirement,
- ➮ The irradiation charges are to be submitted at the time of placing the order, unless alternate agreement is in place. The charges vary from product to product, and you can have a quote for the exact charges by. emailing our product detail to quote@shriraminstitute.org
- ➮ For products that are under the purview of Drug Control Authority, a 'Loan License' from the authority I and an undertaking on prescribed format is a prerequisite
Any variation in the above parameters if required can be discussed before sending the consignment
* The irradiation dose should be selected such that it is sufficient for effecting the expected benefits (sterilization, cross- linking etc.) while the adverse effects (degradation, loss of medical efficacy, physical strength etc.) are minimal. If the optimal dose is not known, SARC can undertake dose optimization studies to help the new customers.
The Gamma Sterilization Advantage
Industrial scale sterilization can be done by several techniques such as dry heating, autoclaving (steam' sterilization), gas sterilization (eg. Ethylene oxide sterilization) etc., besides sterilization using gamma rays. But the sterilization using gamma rays has the following advantages:-
❖ Unlike heat sterilization or steam sterilization, Gamma ray sterilization does not significantly increase the temperature of the products and therefore can be used to sterilize safely even the heat sensitive materials as well as materials in frozen condition.
❖ Unlike Ethylene oxide sterilization, gamma sterilization does not leave any harmful residue. In products exposed to gamma rays from Cobalt-60 source at the normally used dose level, there is no danger of radioactivity or toxicity. Radiation processed products does not become radioactive- just as our body do not start emitting X -rays after being X-rayed.
❖ Gamma sterilization is performed after packaging of the products in the final containers and does not involve any aseptic handling. Product sterility is retained indefinitely, as long as the packaging is intact
❖ Sterilization of products of any shape can be achieved due to the high penetration ability of gamma rays.
❖ Gamma ray sterilization is non-polluting, environment friendly process, and since it is a continuous process, the results are more uniform than gas or high temperature sterilization, which are essentially batch processes.
TEST DESCRIPTION
- ➮ Antibacterial Finish Assessment, Qualitative
- ➮ Antibacterial Finish Assessment, Quantitative
- ➮ Antifungal Activity
- ➮ Resistance to Fungi
METHOD
- ➮ AATCC 147
- ➮ AATCC 100. ASTM E2149
- ➮ AATCC 30
- ➮ ASTM G21
COLORFASTNESS
TEST DESCRIPTION
- ➮ Bleach (Chlorine)
- ➮ Bleach (Non-Chlorine)
- ➮ Burnt Gas Fumes
- ➮ Crocking (Flat or Rotary)
- ➮ Dry Heat (Excluding Pressing)
- ➮ Dye Transfer in Storage
- ➮ Hot Pressing
- ➮ Laundering
- ➮ Light
- ➮ Perspiration (Acid and/or Alkaline)
- ➮ Water (Bleed Resistance)
- ➮ Water (Chlorinated Pool)
- ➮ Water (Sea)
- ➮ Phenolic Yellowing
METHOD
- ➮ AATCC 61/Clorox Method
- ➮ AATCC 172/Clorox Method
- ➮ AATCC 23
- ➮ AATCC 8/116
- ➮ AATCC 117
- ➮ AATCC 163
- ➮ AATCC 133
- ➮ AATCC 61/135/150
- ➮ AATCC 16, ASTM G151/G153/G154
- ➮ AATCC 15, FTM 191A-5680
- ➮ AATCC 107
- ➮ AATCC 162
- ➮ AATCC 106
- ➮ James H. Heals Phenolic Yellowing Test
FABRIC AND APPAREL CONSTRUCTION
TEST DESCRIPTION
- ➮ Thread/Stitch Count
- ➮ Thickness
- ➮ Thread Count)
- ➮ Weave Identification
- ➮ Weight
- ➮ Width
METHOD
- ➮ Microscopic Analysis
- ➮ ASTM D1777
- ➮ ASTM D3775/D3887
- ➮ Visual and/or Microscopic Analysis
- ➮ ASTM D3776
- ➮ ASTM D3774
FIBER / CHEMICAL ANALYSIS
TEST DESCRIPTION
- ➮ Extractions
- ➮ Alcohol
- ➮ Chloroform
- ➮ Hexane
- ➮ Water
- ➮ Fiber Content
- ➮ Qualitative
- ➮ Quantitative - % Reported
- ➮ Formaldehyde Content
- ➮ Melting Point
- ➮ Non-Fibrous Content
- ➮ pH
- ➮ Presence of Labile Sulfur
METHOD
- ➮ AATCC 97, ASTM D629/D2257, FTM
- ➮
- ➮
- ➮
- ➮
- ➮
- ➮ AATCC 20
- ➮ AATCC 20A
- ➮ AATCC 112
- ➮ ASTM D276
- ➮ ASTM D629
- ➮ AATCC 81, ASTM D2165
- ➮ FTM 191A-2020
FLAMMABILITYh
TEST DESCRIPTIOND
- ➮ Automotive Trim Materials
- ➮ Children's Sleepwear)
- ➮ Cloth (Vertical)
- ➮ Drapery / Upholstery Fabric
- ➮ NFPA
- ➮ Shipboard
- ➮ Wearing Apparel
METHOD
- ➮ FMVSS 302
- ➮ CPSC 16 CFR 1615/1616
- ➮ ASTM D6413/F1358, FTM 191A-5903
- ➮ CAL 117, NFPA 701
- ➮ Consult Lab
- ➮ IMO A.471, A.563/A.652/ A.6882
- ➮ CPSC 16 CFR 1610, CS 191-53
LAUNDERING / DRY CLEANING
TEST DESCRIPTION
- ➮ Accelerated
- ➮ Dry Cleaning
- ➮ Home / Hand Laundering
- ➮ Laundering Evaluations
- ➮ Color Change
- ➮ Crease Retention
- ➮ Pilling
- ➮ Shrinkage
- ➮ Skewness (Torque)
- ➮ Smoothness Appearance
- ➮ Smoothness of Seams
- ➮ Soil / Stain Release
METHOD
- ➮ AATCC 61
- ➮ Commercial
- ➮ AATCC 135/150
- ➮
- ➮ AATCC Gray Scale for Color Change
- ➮ AATCC 88C/143
- ➮ ASTM D3512 Photographic Standards
- ➮ AATCC 135/150/158
- ➮ AATCC 179
- ➮ AATCC 124/143
- ➮ AATCC 88B/143
- ➮ AATCC 130, AATCC Gray Scale for Staining, PTL Methods
MOISTURE MANAGEMENTb
TEST DESCRIPTION
- ➮ Absorption
- ➮ Oil
- ➮ Terry Fabrics
- ➮ Water
- ➮ Repellency
- ➮ Oil
- ➮ Water-Dynamic Tumble Jar
- ➮ Water-Spray Test
- ➮ Resistance
- ➮ Hydrostatic Pressure (High and Low)
- ➮ Impact Penetration
- ➮ Rain Test
METHOD
- ➮
- ➮ Consult Lab
- ➮ ASTM D4772
- ➮ AATCC 79, PTL 1090
- ➮
- ➮ AATCC 118
- ➮ AATCC 70
- ➮ AATCC 22
- ➮
- ➮ AATCC 127, ASTM D751
- ➮ AATCC 42
- ➮ AATCC 35, US Customs
PERFORMANCE TESTS
TEST DESCRIPTION
- ➮ Air Permeability
- ➮ Blocking
- ➮ Coefficient of Friction (Static & Kinetic)
- ➮ Component Testing-Buttons, Clasps, other-strength,
- ➮ corrosion, impact etc.
- ➮ Hook & Loop Fastener (Peel & Shear)
- ➮ Odor
- ➮ Resistance to Low Temperature (to - 40° F)
- ➮ Impact
- ➮ Mandrel Bend
- ➮ Roller Method
- ➮ Resistance of Materials to Pink Staining Organism
- ➮ Stiffness
- ➮ Cantilever Drape Flex
- ➮ Tinius Olsen
- ➮ Thermal Protective Performance
- ➮ Ultraviolet Protection Factor (UPF Rating)
- ➮ Wrinkle Recovery
METHOD
- ➮ ASTM D737, FTM 191-5450
- ➮ ASTM D751, FTM 191A-5872
- ➮ ASTM D1894
- ➮ ASTM and PTL Methods
- ➮
- ➮ ASTM D5170/5169
- ➮ SAE J1351, Consult Lab
- ➮
- ➮ ASTM D1790
- ➮ ASTM D751
- ➮ ASTM D751
- ➮ ASTM E1428
- ➮
- ➮ ASTM D1388/D5732
- ➮ ASTM D747
- ➮ ASTM F1060
- ➮ AATCC 183
- ➮ AATCC 128
STRENGTH AND DURABILITY
TEST DESCRIPTION
- ➮ Adhesion
- ➮ Bursting Strength
- ➮ Ball
- ➮ Mullen (Hydraulic Diaphragm)
- ➮ Puncture Resistance
- ➮ Seam Strength
- ➮ Snap Strength
- ➮ Stretch and Elongation
- ➮ Stretch Elastic Fabrics
- ➮ Stretch and Recovery
- ➮ Tear Strength
- ➮ Elmendorf
- ➮ Tongue
- ➮ Trapezoid
- ➮ Tensile Strength and/or Elongation
- ➮ Zipper Strength
METHOD
- ➮ ATM D751
- ➮
- ➮ ASTM D751/D3787
- ➮ ASTM D751/D3786
- ➮ ASTM D751/D4833, FTM 101C-2065.1
- ➮ ASTM D1683
- ➮ ASTM D4846
- ➮
- ➮ ASTM D4964/D5278
- ➮ ASTM D2594/D3107
- ➮
- ➮ ASTM D751/D1424
- ➮ ASTM D751/D2261
- ➮ ASTM D751/D4533/D5587/D5733
- ➮ ASTM D751/D882//D5034/D5035
- ➮ ASTM Methods, SFA Methods