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Medical Device Manufacturer needs medical device laboratory for sterilization validation of device sterilization process.
1.¬ ¬Sterilization method: ¬ We will supply instr¬uctions for a method ¬with step by step ins-tructions and we need¬ to get the steriliza¬tion validation ? the¬y will be autoclaved Yes it is correct but you should validate your steam sterilization parameters, temperature,duration,pressure etc. After you sterilize your products according to your set values. you confirm with sterility test that No Microbial Contamination on products.
Cleaning and Sterilization Instructions
Spring FG Diamond Burs are non-STERILE, but should be cleaned and sterilized before use and subsequent reuse.
Ultrasonic Cleaning Procedure
Prepare a fresh pH-neutral cleaning solution; place the Diamond Bur in the dedicated instrument block (if applicable) and then place in a sonication unit. Follow the agent manufacturers' instructions for correct concentration, exposure time, temperature, and water quality. Completely submerge the device in the cleaning solution and sonicate for at least fifteen (15) minutes.
Perform a final thorough rinse of the device and instrument block (if applicable) under running warm tap water for at least (1) minute. Visually inspect to confirm the removal of debris. Repeat the cycle if needed. Dry the device using a non-shedding wipe or clean compressed air.
inspection Testing 1. Carefully inspect each device to ensure that all debris has been removed. 2. Visually inspect the device for damage/ wear that would prevent proper operation. a. Do not use if the tip is broken. b. Do not use if there are missing or worn diamond particles. c. Do not use if there is evidence of corrosion. Packaging Singly: Pack the Diamond Bur in pouches validated for sterilization In Sets: Place the Diamond Bur in the dedicated instrument block. Sterilization Use the following cycles for steam sterilization Cycle Type Minimum Sterilization Exposure Time (minutes) Minimum Sterilization Exposure Temperature Minimum Dry Time (minutes) Gravity 10 135°C (275°F) 30 Pre-vacuum (4 Pulses) 3 134°C (273°F) 30 Ensure that the sterilizer manufacturer?s maximum load is not exceeded. Storage The Diamond Bur should be stored in the sterilization pouch (or instrument block) until required. Additional Information These processes have been validated as being capable of preparing Spring Diamond Burs for reuse. Any deviation from these instructions should be properly validated for effectiveness and potential adverse results.
2.¬ ¬Cleaning Validation¬
There are two steps
1) cleaning residual on products coming from Production-, grease(oil) from machining and cleaning material residual on piece...
2) decreasing bio burden level...
So you validate and find optimum values for ultrasonic cleaning machine parameters (time,temperature etc) based on criteria Limit above Cleaning
1. If you choose to reprocess burs, avoid delaying following use as this increases the chance of debris drying on the working area. If debris does dry on the burs, they must be cleaned manually with a brush.
2. Burs can be ultrasonically cleaned when inserted in bur blocks or holders to prevent damage from rubbing or vibrating against each other or hard surfaces. An ultrasonic cycle of 5 minutes using a neutral-pH ultrasonic cleaner is recommended.
3. After the ultrasonic cycle, use a brush to remove any remaining debris and rinse under running water.
4. Immediately dry the burs thoroughly with an absorbent towel or paper tissue.
5. After the cleaning process, inspect and discard any burs that show signs of damage or corrosion.\
3.¬ ¬Corrosion Test
Corrosion resistance for metal and alloy products as per ISO 9227
ISO/DIS 10271 1998 Dental Metallic Materials - Corrosion Test Methods (Rev
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