Vacuum is maintained in the cabin for 90 minutes. Ethylene Oxide gas (20% ETO+ 80% CO2) is inserted by pressure, until pressure exceeds 1.44 Bar. Contact remains for 18 hours. After full contact of 18 hours, at a temperature of 32o C (temperature peaks of +80 -20 are permitted), and at pressure of 1.44 Bar, a vacuum is created by removing the Ethylene Oxide until a vacuum of 0.280 Bar is reached. Filtered air is inserted into the autoclave until atmospheric pressure is reached. Vacuum is again applied, and after inserting filtered air once again, the procedure is repeated 7 times consecutively. For ventilation, 1 additional smaller cycle, to 0.730 Bar, is performed to remove residues of ETO before opening of the chamber. Validation of each particular sterilization process – Conformity Tests: During the process of loading the autoclave, as routine control, 24 packs of pre designed tubes containing nX106 different bacteria and spores are placed in 24 positions in the autoclave, according to pre determined positions. These spores are tested for efficiency of sterilization. Results are obtained after 48 hours. 12 other packs, without spores and bacteria are placed in pre determined and fixed positions and again tested for sterilization efficiency of gram positive and gram negative bacteria. Results are obtained after 14 days. In addition to microbial tests, 24 chemical detectors, as part of the biological indicator that are marked on it to show efficiency of the gas. Minimum 4 times per year, the residues of ETO in the products after 48 hours, are tested according to ISO 10993-7:2008 with the highest limit of 10 PPM (10 gr. Per litter). 2. Preparation for Validation process: 2. 1 Introduction of 25 temperature sensors and 10 humidity sensors after being pre-validated for the accuracy of 0.50 C of the temperature and 1% of relative humidity, into the chamber plus 1 sensor of temperature and one sensor humidity kept out of the chamber. The 35 sensors are introduced into the chamber through a 38mm opening in the side of the chamber, – see attached photograph. 2. 2 The pressure gage of the chamber was validated on July 2012 during the annual validation of measuring devices. 2. 3 Chamber loaded with 6 pallets containers that contain products for sterilization. Each container is approximately 220cm wide, 180cm deep and 180cm height and the distance between each pallet is minimum 5cm to permit air ventilation. 2. 4 The 25 temperature sensors – numbered from 1 – 25 are placed into the packs in the pallets as per attached diagram. 2. 5 The 10 humidity sensors numbered from 1- 10 are placed into the packs in the pallets as per attached diagram – labeled in diagram no. 2. Temperature sensor no. 26 and humidity sensor no. 11 are placed outside the chamber near the center of the chamber, at a distance of about 40 cm from the ceiling. 2. 6 The temperature sensor of the sterilizer was placed between carriage no. 3 and 4, at a distance of 90 cm. from the base of the carriages. 2. 7 Measurements: The total volume of the chamber is 24M3 and the goods are placed on 6 pallets. Distance between the pallets and the side walls of the sterilization walls ~ 8 cm, Distance between the top layers of the pallets to the ceiling ~ 10 cm.
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Distance between each pallet minimum 5 cm. 2. 8 Each pallet was covered with polyethylene sheet and wrapped with shrink polyethylene. 2. 9 44 biological indicators of 1.6X106 were placed into 44 rigid packs of PVC sealed by Tyvek lid. The packs were placed into the pallets according to the attached diagram. One biological indicator fro same lot was placed outside the chamber. 2. 10 24 packs containing actual products simulating the contents of the sterilized products were placed in pairs according to enclosed diagram labeled with numbers from 1-12 and 1a-12a for each pair. 2. 11 Samples of packaging packs, were tested for peel strength before sterilization (QA-0707) and the data was recorded.