tunnel thermographs

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TUNNEL THERMOGRAPHS Submitted to:- Dr. Gangadhrappa Asst professer Dept of pharmaceutics Jsscp, Mysore Pharmaceutical Quality Assurance, Dept of Pharmaceutics 1 Submitted by:- Ram Mohan S.R. 1 st M pharm PQA Jsscp, Mysore

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Page 1: Tunnel thermographs

1TUNNEL THERMOGRAPHS

Submitted to:-

Dr. Gangadhrappa

Asst professer

Dept of pharmaceutics

Jsscp, Mysore

Pharmaceutical Quality Assurance, Dept of Pharmaceutics

Submitted by:-Ram Mohan S.R.1st M pharm PQAJsscp, Mysore

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Pharmaceutical Quality Assurance, Dept of Pharmaceutics

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STERILIZING TUNNELS

• Tunnel Sterilizer 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 parentral product packing.

• 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.

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• The destruction process of microorganisms is a function of time and temperature. The rate of destruction is linear logarithmic, means in a given time interval and at a given temperature, the same percentage of the bacterial population will be destroyed Hence “Forced Conventional Dry Heat Sterilizer” (Sterilizing Tunnel).

• The Forced Conventional Dry Sterilizer consists Drying / Pre- Heat Zone Sterilizing Zone  Cooling / Stabilizing Zone

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Drying / Pre- Heat Zone• EU -7 grade Pre filter.

• Motor Blower assembly.

• EU 13 grade Minipleat Filter utilizing state - of - art hot melt technology.

• Mechanical differential pressure gauge to monitor pressure drop across final filter with respect to ambient.

• Proximity sensors, provided at infeed for dictation of vials/ampoules overload, and interlocked with START/STOP of conveyor operation.

• Integrated PT 100 temperature sensor to monitor temperature in the specified zone.

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Sterilizing Zone 

• Double wall asbestos free ceramic wool insulated recirculatory module containing high temperature EU - 13 grade final HEPA filter with suck back mechanism suitable for 350 0C continuous repeated cycle.

• This zone provides uniform hot air over the glassware for the purpose of depyrogenation. 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 consists of unidirectional hot air flow unit with turbine blower assembly, high temperature HEPA filter (upto 350 0C) and heater bank assembly.

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• 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 of temperature a Thermostat is placed for protection of heaters.

• The entry and exit to the sterilizing zone consists of manually adjustable profile plates resulting in maximum temperature uniformity and ensure consistent result for glassware with varying sizes.

• Mechanical differential pressure gauge to monitor pressure drop across final filter with respect to ambient.

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Cooling / Stabilizing Zone

• 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.

• Mechanical differential pressure gauge to monitor pressure drop across final filter with respect of ambient.

• 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.

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BOSCH TUNNEL

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