Neelam Industries ISO CLASS 5 Depyrogenation tunnels is a fully automated system which utilizes dry heat by means of forced convection of filtered air, through high efficiency particulate air filter to achieve sterilization and depyrogenation of washed empty pharmaceutical glassware used of parenteral product packing.
Neelam Industries continuous dry heat sterilizer ensures the glassware to exposed for depyrogenation temperature. The time required for the necessary reduction in endotoxins which at bare minimum is > LOG 3 at rated output.
The Sterilization Depyrogenation cycle is based on selection of cycle times and exposure of temperature that will sterilize or depyrogenate the glassware to an acceptable low probability level of contamination, without adversely affecting the critical parameters of the product.
The Forced Conventional Dry Sterilizer consists of Drying Zone to raise the temperature of the glassware and evaporate the wash water from the glassware. The Sterilizing Zone sterilize the glassware at 300 °C and the third section consist of cooling & sterilizing zone to restore the glassware temperature to ambient.
Sterilizing Zone II
Sterilizing Zone Comprises of
- Double wall asbestos free ceramic wool insulated re circulatory module containing high temperature EU - 13 grade final HEPA filter with suck back mechanism suitable for 300 °C continuous repeated cycle.
- This zone provides uniform hot air over the glassware for the Purpose of de pyrogenation. In this zone the temperature raises as quickly as Possible by the help of heating element, without inducing cracking due to excessive thermal stress. The glassware remains in this zone at a required time period to meet The specified endotoxins reduction generally > 3 log scale.
- This section consist of unidirectional hot air flow unit with turbine blower assembly, High temperature HEPA filter (up to 350 °C) and heater bank assembly.
- Integrated temperature sensors are provided for monitoring & controlling purpose of Temperature inside the sterilizing zone. For this purpose one sensor is placed above The HEPA filter and the sensor is placed at the entry side of sterilizing zone. For Extra precaution one temperature sensor provided at Heater Assembly ( 375 °C) is placed for protection of Heaters.
- The entry and exit side of the sterilizing zone consists of manually adjustable profile Plates resulting in maximum temperature uniformity and ensure consistent result for Glassware with varying sizes.
- Differential Pressure gauge installed to monitor pressure Drop across final filter.
Cooliing / Stabilizing Zone II
SS 304 Module Containing
- EU - 7 grade Pre filter.
- Motor Blower assembly.
- EU - 13 grade Minipleat Filter utilizing state- of - art hot melt technology.
- Integrated PT 100 temperature sensor provided to monitor temperature In the specified zone.
- Differential pressure gauge installed to monitor pressure drop across final filter.
- Extract blowers, provided underneath conveyor for cooling and stabilizing zone with Discharge duct which is integrated with vapour extract exhaust duct from Drying / Pre Heat Zone.