26 Aug The recovery of Endotoxin Concentration after exposing to Depyrogenation tunnel should show more than 3 log reduction. Three run to be. Content: • Definition of Sterilization and Depyrogenation Dry Heat Depyrogenation Theoretical requirement: . continuous (Tunnel) sterilizer validation is. Validation Protocol for Sterilization and Depyrogenating Tunnel used in sterile be compiled to evaluate ability of the sterilization and depyrogenation tunnel to.

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Air does not move from dirty to clean.

Ankur Choudhary is India’s first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since Download the data from the data logger in the computer for the data analysis and printing enclosed the printout obtained from the data logger. Once you have the belt speed, temperatures and worst case location, you can start validatin testing.

A minimum of a three log reduction in endotoxin must be demonstrated. Name of testing instrument: Data Logger with Minimum 12 Probes duly calibrated. We are trying to shorten our oven depyrogenation cycle from 3 hrs dwell at C to 15 min dwell C.

Rate of speed, minimum, maximum and nominal, will be measured and verified. Name of the trainer: Note this is for the sterilization of the cooling zone only. Performance Qualification PQ Heat penetration studies: Dear Forum, What z-value and reference temperature value shall be used in calculating Fh for a depyrogenation cycle, using dry heat oven? Conclusion will be drawn after compilation and evaluation of result.


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In deed the thermosensors we are using have 6m length, therefore no problem on that. No containers should be damaged, none hung up, or dislodged.

Operational Qualification Acceptance Criteria Setpoints. All instruments shall be calibrated before starting and after completion of validation studies. Continuous processes can be performed in a depyrogenation tunnel, where product is conveyed through different temperature zones while being transported from one area to another. Traditional thermocouples have the issue of feeding into the tunnel and then the potential for them to move is present.


The BET indicators vials shall be placed next to the vials carrying the thermocouples. Additionally, door interlocks should be used for both safety and to prevent flow between clean and dirty process areas. Then you can make a comparison between empty chamber FH values and full chamber FH values. During execution of this protocol, if any deviation is noticed, the person executing the protocol initiates a deviation report and provides the detail description of the deviation.

HEPA Filter integrity testing. Infrared tunnels, which heat components, not the air, cannot be mapped in the absence of bottles. What type of thermosensors are you using? The Tunnel zones are balanced per the manufacturer specifications.

Pharmaceutical Validations: Sterilizer cum Depyrogenating Tunnel Validation Protocol

Your help is very much appreciated, since I have to perform the thnnel tomorrow noon. The tunnel will be temperature mapped to demonstrate consistency. Visitors are also reading: Total Particulate Counts The oven must meet specifications for total particulates. Hello, I am wondering as to the Z-values to use during verification validatiln tunnel cooling zone sterilization.


Typically tunnels run at a very high temperature and most stand alone sensors cannot withstand the heat. PDA Technical Report no.

U.S. Valdiation Services – Depyrogenation Tunnel

Also provides various aspects of validation using biological and endotoxin indicators. For depy process you need to have more than 3 log of EU endotoxin unit and Fd greater trhen For over kill approach you can icrease the sterilization time in hot zone.

Thanks Shahnawaz for your reply, Just for my understanding, for a temperature of C, I would use a z-value of?? The unit will be mapped empty with temperature sensors placed throughout the oven to measure uniformity, stability, and repeatability. Thanks and best regards.

Physical handling of containers will be monitored. Additionally, it is imperative that sensors are located in the hardest-to-heat location within each load item and, if applicable, the hardest-to-heat load item is placed in the hardest-to-heat location within the chamber. What I plan to do is to use 8 thermosensors placed on the same line and have them pass through the tunnel under the requested period of time and the set temperature.

Air Borne Particulate Counter, duly calibrated with traceability certificate.