Ellab Thermal Validation System – Pharmaceutical Application

Description

Ellab Thermal Validation System – Pharmaceutical Application

Brand : Ellab – Denmark

1. AUTOCLAVE VALIDATION

 

• Ellab EVal Flex Online Cable Based System and TS Pro Wireless Datalogger can be used for the validation of Autoclaves.
• The EVal Flex system is supplied with Thermocouple Probes with concealed connectors provide high accuracy and reliability. The accuracy of the System with the probe is +/-0.05 deg C after calibration and 0.1 deg C before calibration.
• The Thermocouple probes are equipped with electronic ID and memory for calibration values which improves the accuracy to 0.05 deg C and ease of thermocouple identification. The identification number is engraved at the Jack Plug and at the tip of the measuring needle helps the operator to position the probes properly. The same ID is shown in the software for identification of the probes.
• Calibration can be performed manually using the current metrology or completely automated with the reference standard data streamed into the calibration files as well as the ram control of the bath.
• The Hardware, Software and Firmware are developed in accordance with guidelines setout in GAMP 4. The ValSuite Pro software has been validated and is fully compliance with FDA 21 CFR Part 11.

 

 

Heat Distribution Data of Autoclave using Ellab EVal Flex 20 Channel System

 

Heat Penetration Applications

• Apart from standard Heat Distribution Studies, Ellab Eval Flex Systems can be used for the Heat Penetration Studies also. The needles of the probes are designed to be compatible to measure the core temperature of products packed in different types of containers

 

ELLAB WIRELESS DATA LOGGER FOR AUTOCLAVE VALIDATION

 

Ellab TS Pro Wireless Dataloggers can be used for the Validation of Autoclaves. It can be used for the Heat Distribution as well as Heat Penetration Applications. The needles of the probes are designed to be compatible with different types of containers. We offer fittings and fixtures to any type of containers.
This equipment is CE-approved, ISO certified and manufactured according to international standards, the software packages are validated according to GAMP, and the measuring results are approved by EEC-Regulations, FDA/USDA and other regulatory authorities worldwide.

 

The TrackSense® Pro Wireless Datalogger is engineered with flexibility and speed. The station has 4 positions for loggers and is connected to the PC via USB, RS232 or Ethernet. By using the USB port power is supplied directly from your PC reducing the need for an external power source. Up to 3 additional expansion modules can be connected to the station allowing the capability to program or download 16 loggers at one time.
The TrackSense® Pro loggers communicate via induction greatly improving the speed and reliability of data transfer.
Thousands of data points from multiple loggers can be downloaded in less than ten minutes. The software will automatically cycle through each logger it finds in the station enabling the operator to walk away during data transfer

 

Autoclave Validation Data using Ellab TS Pro Wireless Datalogger is shown above. The temperature of the medium of autoclave (Heat Distribution) , the temperature of the core of the products packed in sealed containers (Heat Penetration), Sterilization values ( Fo values) of the products, Autoclave pressure etc are shown in the above graph.
The Hardware, Software and Firmware are developed in accordance with guidelines setout in GAMP 4. The ValSuite Pro software has been validated and is fully compliance with FDA 21 CFR Part 11.

MEDICAL AUTOCLAVE VALIDATION

 

The above picture shows the Medical Autoclave Validation using Ellab TS Pro System. The positive and negative pressure pulses (in order to apply vacuum), Heat up phase, Sterilization phase, Post vacuum phase, drying phase, equilibration phase etc can be very well estimated and documented in the graph.
It is possible to analyze each section and to make sure that all the sections are working well within the limits.

DEPYROGENATION / DRY HEAT STERILIZERS
Depyrogenation is normally performed in a batch-wise manner or using tunnels in a continuous process.
Ellab offers complete solutions for the validation of Depryogenation / Dry Heat Sterilization applications. For stationary Batch Hot Air Ovens, we offer EVal Flex with High Temperature Probes which can go upto +400 deg C.
For Tunnel types of Depyrogenators, we offer TS Pro Wireless Dataloggers with special Loggers and Sensors with protectors which can be used upto + 400 deg C. Special Insulation Packs (Thermal Barriers) are being used to insulate the logger when it is being used at extreme temperatures.

The Sensors of the loggers are supplied with flexible metal insulated wires which can be positioned exactly at the cold spot of the containers. The thin profile of the sensors does not block the flow of the hot air into the bottom surface of the vials and bottles
which helps to simulate the actual process conditions. Please refer the above mentioned picture showing the positing of the tip of the measuring sensor inside the vials and the parts of the Thermal Barrier to protect the electronic parts of the logger from extreme temperatures.

The Ellab EVal Flex Cable Based system also can be used for the validation of the Depyrogenatiors / Dry Heat Sterilizers using the special High Temperature Thermocouple Probes. The High temperature probes can be used to measure temperatures upto + 400 deg C.
The Hardware, Software and Firmware are developed in accordance with guidelines setout in GAMP 4. The ValSuite Pro software has been validated and is fully compliance with FDA 21 CFR Part 11.

 

Data from Ellab system showing the validation of tunnel Depyrogenation applications. The temperature range was about 300 deg C. Ellab systems can measure upto 400 deg C

EtO (Ethylene Oxide) Sterilization and H2O2 (Hydrogen Peroxide) Sterilization
These compounds are strong oxidizing agents which are used to sterilize products that can not withstand heat. These agents are used in the gaseous phase and penetrate the products over a period of hours.

EtO Sterilization Standard Procedure.

• Pre conditioning – expose product to tropical environment for at least 12 hours – 55°C/70% RH.
• Exposure – pull vacuum and expose to gas usually for 4 to 8 hours (varies per product and must be validated).
• Post conditioning – air out all the EtO gas. 8-12 hours
• Temperature and RH% are critical in pre-conditioning to induce microbial activity EtO will not kill many microbes in their dormant or (spore) stage.
• Moisture is critical as a transfer agent for EtO – it helps to permeate through plastic, paper, cardboard, packaging etc.
• Pulling a vacuum dramatically dries out the product. Therefore steam (RH) is increased to replace lost moisture in the product.
• The influence of pressure is also a factor in helping EtO permeate a product. Pulling a vacuum pulls EtO into product.

Ellab TS Pro Wireless Datalogger offers total solution for the validation of EtO and H2O2 Sterilization.
The Temperature, Pressure and Humidity can be measured using TS Pro Loggers.
Ellab offers special PRO Ex Logger for EtO Sterilization having the temp range of -50 to +150 C. The Ex Logger is designed for use in explosive environments i.e. where aggressive gases such as EtO are used for sterilization. The temperature range of Pro Ex Logger is from -50 to +150 C and is Ex approved, which is incorporated in the Atex Directive 94/9/EC. The certificate for Ex is mandatory when using loggers for EtO applications. Similarly Special Loggers are designed for measuring Humidity inside EtO sterilizers.

 

The Data from Ellab TS Pro Logger showing the Temperature, Pressure and Humidity inside EtO Sterilizer.

FREEZE DRYING ( LYOPHILISATION )
Freeze Drying ( Lyophilisation) is the process of removing water from a frozen solution by Sublimation. The product is frozen to very low temperature (-40 C and below) and then slowly heated in the presence of vacuum. The result is the water sublimes and is captured on condensers at extremely low temperature (-80 C and below).
Freeze Drying consists of 3 stages: Freezing, Primary Drying (removal of water present as ice crystals) and Secondary Drying (removal of water bound to the product). The critical factors in a freeze drying process are the shelf temperature, chamber
pressure and product temperature.
Ellab Offers complete solutions for the Freeze Drying Validation and Monitoring.
PRO X Logger ( -80 to +150 C) is designed for difficult low temperature applications. The data logger can run studies in excess of 250 hours at -80 oC degrees. This data logger is appropriate for a range of applications such as mapping -80 oC
freezers and lyophilizers with low temperature and vacuum. The thin ( 1.2 mm diameter) sensors are perfect for monitoring temperatures in vials.
The Pressure Loggers can measure the pressure from 10mBar to 6 Bars absolute. The Pressure sensors can be supplied
with special sensors which can measure the chamber pressure as well as pressure inside the containers.
We offer special sensors with fittings and fixtures to fix to any type of containers in order to measure the temperatures of the products as well as the chamber temperature.

 

 

INCUBATOR / STABILITY CHAMBER VALIDATION – Temperature & Humidity
WASHER DISINFECTORS, REFRIGERATOR, COLD STORES, HUMIDITY CHAMBERS, HEATING CHAMBERS, ENVIRONMENTAL CHAMBERS ETC.

• The TrackSense Lab Logger has been designed to meet the temperature monitoring and validation requirements for freezers, refrigerators, stability chambers, incubators etc. The logger monitors the temperature between -30 to + 100 deg C with an accuracy of +/-0.1 C and +/-2 % RH. To simplify the operation, a three color LED will assist the operator with instant information about the status of the logger.
  The TS PRO SKY Logger transmits the data online which is helps the customer to monitor the processing online.