GENERAL FAQ FOR STABILITY CHAMBER
Q.1 How do I purchase the Equipment? Q.2 What capacity should I select? Q.3 How do I select the model? Q.4 What options are available along with the equipment? Q.5 Which is the most essential option required for the smooth functioning of the stability chamber? Q.6 With which Optionals, can a chamber be upgraded at a later stage? Why? Q.7 Is it necessary to have separate chamber for each ICH condition given? If 'yes' then are such separate chambers available?
TECHNICAL FAQ
Q.8 What is the adjustable height of tray? Q.9 What is the size of each tray? Q.10 What are the max. no. of trays that can be accommodated in a chamber? Q.11 What is the max. load recommended for each tray? Q.12 Whether the uniformity of condition is achieved in loaded condition? Q.13 What refrigerant is used? Q.14 What is CFC Free? Q.15 Is their any electronic control terminal installed for data control of set points and actual values, easy adjustment of set point values, storage of individual programmes which can be called up without any programming knowledge? Q.16 What is the "system protection class"? Q.17 What is CE approved? Q.18 In what way are UK /Japanese controller are superior to other make controllers? Q.19 Do the controllers comply with EMC (electro-magnetic compatibility) test in accordance with EN 55011, in terms of Conducted interference class, Emitted Interference class, Interference immunity according to EN 50082 etc? Q.20 What is Dedicated Safety Controller? Q.21 What if the dedicated safety controller fails? Q.22 What is the sound pressure level (in dB(A) at free field measuring in a distance of 1 m from the front & What is the acoustic power level, in terms if dB (A)? Q.23 Whether audio / visual alarms are available if set conditions are crossed / not reached?
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INSTALLATION RELATED FAQ
Q. 24 How much floor space is required to install a chamber? Q. 25 What is the dimension of door? Q. 26 What is the gross weight of chamber? Q. 27 What is the overall weight and size of chamber after packing? Q. 28 What is the heat emission behaviour of the chamber, around in the area? Q. 29 What is the power supply requirement of a chamber? Q. 30 What is the current consumption at each of the ICH conditions, separately? Q. 31 What is the water drain system? Pressurized or unpressurized, details? Q. 32 What is the humidification water used, its pH, conductivity and whether level indication (float control and low water alarm) are available? Q. 33 Why only DM or Distilled water is recommend for the chamber? Q. 34 What is the water consumption at each of the ICH conditions, separately? Q. 35 Whether re-circulation of the residues / process - water is possible?
POST INSTALLATION RELATED FAQ
Q. 36 Does Thermolab provide Warranty for its Equipment? If "Yes" than what is included in the warranty? Q. 37 Does Thermolab install their equipment?
Q. 38 What do I do to install the Equipment? Q. 39 Are Spares available for the Thermolab Equipment? Q. 40 Does Thermolab provide the revalidation and calibration service? Q. 41 Who do I Contact for servicing Thermolab Equipment? Q. 42Do you undertake the maintenance of the equipment after the warranty period of the equipment is over? Q. 43 Is it worth purchasing Thermolab Equipments?
Q1. How do I purchase the Equipment?
Select the Capacity, Model available with the desired Optionas and send us the enquiry so that we can provide you with our best offer. To send the enquiry please fills the enquiry form. Thermolab has its Sales Representative located at different region who will contact you for further techno-commercial discussions.
Q2. What capacity should I select?
One should select the capacity of the equipment considering the volume of the samples to be tested and the space available with you to install the equipment. a) Incase you are the first time user / new project with a less volume of samples it is recommend to select 200 Ltrs. Capacity to start with. If you expect an increase in the volume of samples to be tested, then we strongly recommend 400 Ltrs. that is generally used in the Industry. Also the price difference between 200 Ltrs. & 400 Ltrs. is just 20% with double the capacity. b) In case you have large volume of sample to be tested you can select 800 or 1000 Ltrs. or Walk-In Type Chamber with respect to the requirement.
Q3. How do I select the model?
We provide two models STD - which is made of Inside S.S.304 and Outside Powder coated. GMP - which is made of Inside S.S.316 and Outside S.S 304. If the installation environment is highly corrosive than it is recommended to select the GMP model. Also the GMP model does not require any painting or maintenance since the entire body is made up of Stainless Steel, which guarantees a life of more than 15 years. You can select any of the two Models since apart from the material of construction all the other features and specification are same.
Q4. What options are available along with the equipment?
The options available with the Stability Chamber are as follows : - --Stand by refrigeration system (For 800 Ltrs. and above ) --Stand by humidity except for 90 ltrs. --Direct % RH electronic capacitor type humidity sensors, which will avoid wick cup and water. --Dedicated Safety system to shut off the boiler heater and air heater in case of over shoot of temperature giving audio video alarm. --PC Interface communication card with RS 485 for above control system. (Hardware for each chamber) --CFR 21 Part 11 compliance Window based communication software for data management. Complete with RS 485 multi dropping to monitor multiple chambers on one software. --Scanner 4-point temperature and 4-point humidity OR Scanner 8-point temperature and 8-point humidity scanner complete with sensors and printer interface and data storage facility. --Additional S. S. perforated trays. --Water storage stainless steel tank of 30 ltrs capacity with 2 tap connection, lid and stand. --80 Col. Dot Matrix Printer along with Stainless Steel Stand.
Q5. Which is the most essential option required for the smooth functioning of the stability chamber?
The most essential option required for the smooth functioning of the Stability Chamber are as follows- a) Direct % RH Direct % RH sensor is essential, as it will avoid the wick cup requirement. It is electromagnet capacitor type sensor, which does not require water or wick cup and is totally maintenance free. b) Dedicated Safety System A dedicated safety controller is provided on the control panel which will cut off the mains supply giving audio visual alarm in case the inside temperature overshoots or undershoot the set temperature by 5 deg. C. It is called dedicated because it is a separate controller with separate Input (sensor) and a separate output and has no connection with the PID controllers used to control the temperature and humidity conditions. Also the controller will cut off the mains supply in case of low water level in the boiler tank, which safeguards the boiler heater. It is essential, as it not only avoids spoiling of the samples but also saves the time in Re-testing, as the time is very valuable for launching the product. c) S.S. Perforated Trays Thermolab supplies 2 Nos. S.S. perforated trays along with each chamber. Considering the volume of the samples to be tested you can select the extra no. of trays as per your requirement. The maximum no. of trays that can fit in the chamber is available in the Technical Data Sheet. d) Stand by Refrigeration System If you are selecting 800 or above models then Stand by Refrigeration System is one of the essential optional. Thermolab chambers are having a regular refrigeration system, which consists of compressor, evaporator, condensor and condensor motor to achieve a temperature below ambient up to 20°C. The stand by refrigeration system is another identical set of the above components which is ready for use in case the above regular refrigeration system fails. It is essential, as the chamber cannot be kept under break down condition for servicing. The standby refrigeration system can be immediately switched 'ON' and in the mean time the regular system can be serviced or repaired. The above is available only for models except 200 and 400ltrs. Stand by refrigeration not only avoid spoiling of the samples but also saves the time in Re-Testing as the time is very valuable for launching the product. e) Stand by Humidity System Thermolab chambers are having a regular humidity system, which consists of boiler heater, float valve and safety low water level float switch, which generates the humidity. The stand by humidity system is an additional heater provide in the tank. If the regular heater burns out or fails one can switch on the switch provided on the control panel. In the mean time the regular system can be services or repaired. The above feature is available for all models. Stand by Humidity not only avoid spoiling of the samples but also saves the time in Re-Testing as the time is very valuable for launching the product. f) Printer Thermolab Stability chamber has the printer interfacing facility. To avail this facility i.e. to take the printouts of the date from the printer-interfacing unit one requires an 80-column dot matrix Epson LX 300 printer.
The most essential option required for the smooth functioning of the Stability Chamber are as follows-
a) Direct % RH Direct % RH sensor is essential, as it will avoid the wick cup requirement. It is electromagnet capacitor type sensor, which does not require water or wick cup and is totally maintenance free.
b) Dedicated Safety System A dedicated safety controller is provided on the control panel which will cut off the mains supply giving audio visual alarm in case the inside temperature overshoots or undershoot the set temperature by 5 deg. C. It is called dedicated because it is a separate controller with separate Input (sensor) and a separate output and has no connection with the PID controllers used to control the temperature and humidity conditions.
Also the controller will cut off the mains supply in case of low water level in the boiler tank, which safeguards the boiler heater. It is essential, as it not only avoids spoiling of the samples but also saves the time in Re-testing, as the time is very valuable for launching the product.
c) S.S. Perforated Trays Thermolab supplies 2 Nos. S.S. perforated trays along with each chamber. Considering the volume of the samples to be tested you can select the extra no. of trays as per your requirement.
The maximum no. of trays that can fit in the chamber is available in the Technical Data Sheet.
d) Stand by Refrigeration System If you are selecting 800 or above models then Stand by Refrigeration System is one of the essential optional.
Thermolab chambers are having a regular refrigeration system, which consists of compressor, evaporator, condensor and condensor motor to achieve a temperature below ambient up to 20°C. The stand by refrigeration system is another identical set of the above components which is ready for use in case the above regular refrigeration system fails. It is essential, as the chamber cannot be kept under break down condition for servicing. The standby refrigeration system can be immediately switched 'ON' and in the mean time the regular system can be serviced or repaired. The above is available only for models except 200 and 400ltrs. Stand by refrigeration not only avoid spoiling of the samples but also saves the time in Re-Testing as the time is very valuable for launching the product. e) Stand by Humidity System Thermolab chambers are having a regular humidity system, which consists of boiler heater, float valve and safety low water level float switch, which generates the humidity.
The stand by humidity system is an additional heater provide in the tank. If the regular heater burns out or fails one can switch on the switch provided on the control panel. In the mean time the regular system can be services or repaired. The above feature is available for all models.
Stand by Humidity not only avoid spoiling of the samples but also saves the time in Re-Testing as the time is very valuable for launching the product.
f) Printer Thermolab Stability chamber has the printer interfacing facility. To avail this facility i.e. to take the printouts of the date from the printer-interfacing unit one requires an 80-column dot matrix Epson LX 300 printer.
Q6. With which Options, a chamber can be upgraded at a later stage? Why?
a) PC Interface (Hardware). PC Interface (optional) with 2 way communication and RS 485 with multi dropping (for multiple chambers) hardware protocol allows remote monitoring, for central data logging to control all the connected chambers. b) WINDOW BASED COMMUNICATION SOFTWARE : Windows based software having reports in tabular as well as in graphical form. Mean kinetic temperature (MKT) calculation as defined in USP 241NF19. Software complies to 21 CFR part 11 protocols. c) SCHEDULER SOFTWARE (OPTIONAL): Scheduler software is a software application that manages the day-to-day activities of the stability department within the quality control and / or R&D division. Its design takes into consideration the latest guidelines from the FDA, 21 CFR part 11, ICH and EU, among others, pertaining to pharmaceutical, chemical, biological and biotechnological fields. This software is designed for all types of products, from pre-clinical to post market, innovator or generic. d) Scanner. Scanner Digilog (optional) 8 Channel ( 4 temperature + 4 humidity) scanner or 16 channel ( 8 temperature + 8 humidity) to print date, time, temperature and humidity value for mapping of temperature and humidity conditions at various points in the chamber. Available with online printing and offline printing for validation purpose. e) Water Tank. The above can be upgraded at a later stage since they don't require major modification in the chamber.
a) PC Interface (Hardware). PC Interface (optional) with 2 way communication and RS 485 with multi dropping (for multiple chambers) hardware protocol allows remote monitoring, for central data logging to control all the connected chambers.
b) WINDOW BASED COMMUNICATION SOFTWARE : Windows based software having reports in tabular as well as in graphical form. Mean kinetic temperature (MKT) calculation as defined in USP 241NF19. Software complies to 21 CFR part 11 protocols.
c) SCHEDULER SOFTWARE (OPTIONAL): Scheduler software is a software application that manages the day-to-day activities of the stability department within the quality control and / or R&D division. Its design takes into consideration the latest guidelines from the FDA, 21 CFR part 11, ICH and EU, among others, pertaining to pharmaceutical, chemical, biological and biotechnological fields. This software is designed for all types of products, from pre-clinical to post market, innovator or generic.
d) Scanner. Scanner Digilog (optional) 8 Channel ( 4 temperature + 4 humidity) scanner or 16 channel ( 8 temperature + 8 humidity) to print date, time, temperature and humidity value for mapping of temperature and humidity conditions at various points in the chamber. Available with online printing and offline printing for validation purpose.
e) Water Tank. The above can be upgraded at a later stage since they don't require major modification in the chamber.
Q7. Is it necessary to have separate chamber for each ICH condition given? If 'yes' then are such separate chambers available?
It's recommended to have separate chambers for separate test since the chamber are required to run continuously for long duration for a particular condition Thermolab manufactures its chamber with respect to the ICH requirement. These chambers can be used for any of the specified ICH Test. Since it has a range of 20 deg. C. to 60 deg. C. and 40% RH to 98% RH
Q8. What is the adjustable height of tray?
In Thermolab Stability Chamber height of each tray is adjustable at every 6". Each tray can be removed and placed as per the height of the test samples.
Q9. What is the size of each tray?
The size of each tray varies as per the capacity of chamber. The approximate tray size is the inner size, length & breath of the chamber.
Q10. What are the max. no. of trays that can be accommodated in a chamber?
The max. no. of tray that can be accommodated varies as per the capacity of chamber which is as follows: Capacity of Chamber Max No. of trays 90 Ltrs 2 200 Ltrs 4 400 Ltrs 7 800 Ltrs 9 1000 Ltrs 11
The max. no. of tray that can be accommodated varies as per the capacity of chamber which is as follows:
Q11. What is the max. load recommended for each tray?
Max. load recommended for each tray is 25 to 30 kg.
Q12. Whether the uniformity of condition is achieved in loaded condition?
Thermolab ensures the uniformity of condition through out the chamber even under loaded condition. We use 2 Nos. blower (instead of 1 No. in other make chamber) for our 400 and above model which ensure 100% uniformity. (This can be demonstrated to you during the validation process at site)
Q13. What refrigerant is used?
The refrigerant used is R134, which is CFC Free refrigerant.
Q14. What is CFC Free?
CFC free means Chloro Flouro Carbon free i.e. it's an Eco friendly refrigerant, which is an ingredient in the refrigerant gas, which caused damages to ozone layer, and hence it is banned worldwide.
Q.15. Is their any electronic control terminal installed for data control of set points and actual values, easy adjustment of set point values, storage of individual programmes which can be called up without any programming knowledge?
The control system is very simple to operate. We use only imported UK / Japanese make controllers, which can be set very easily. In case of power failure the chamber will start on its own with old set point after the power is restored. Also the set and actual reading will be stored in the unit up to 30 days.
Q.16. What is the "system protection class"?
The entire system has been protected with the help of individual fuse, overload for compressor, 2 min time delay for compressor, over temperature and also under shoot of set temperature. Low water level cut off etc. The controllers used are CE approved.
Q17. What is CE approved?
CE approved is a Certificate of Excellence required in the European Market for all electrical products for the safety.
Q18. In what way are UK /Japanese controller are superior to other make controllers?
These Microprocessor based PID controller are very accurate and reliable and gives an accuracy of ± 0.2 deg. C. for temperature and ± 2% RH for humidity. These controllers are being imported from UK or Japan and are the same controllers used on any Imported Brand of Chambers. We are using these same control systems and hence we claim the performance of the chamber equivalent to any other make (Imported) chambers. These are standard controllers and manufacture in millions of quantity and also available in any Country, which may be required for replacement or possible repairs.
Q19. Do the controllers comply with EMC (electro-magnetic compatibility) test in accordance with EN 55011, in terms of Conducted interference class, Emitted Interference class, Interference immunity according to EN 50082 etc?
The controller is having the protection from Electro Magnetic Disturbance. The control system is CE approved and hence has all the required protections.
Q20. What is Dedicated Safety Controller?
A dedicated safety controller is provided on the control panel which will cut off the mains supply giving audio visual alarm in case the inside temperature overshoots or undershoot the set temperature by 5 deg. C. It is called dedicated because it is a separate controller with separate Input (sensor) and a separate output and has no connection with the PID controllers used to control the temperature and humidity conditions. Also the controller will cut off the mains supply in case of low water level in the boiler tank, which safeguards the boiler heater. It is essential as it not only avoids spoiling of the samples but also saves the time in Re-testing, as the time is very valuable for launching the product.
A dedicated safety controller is provided on the control panel which will cut off the mains supply giving audio visual alarm in case the inside temperature overshoots or undershoot the set temperature by 5 deg. C. It is called dedicated because it is a separate controller with separate Input (sensor) and a separate output and has no connection with the PID controllers used to control the temperature and humidity conditions.
Also the controller will cut off the mains supply in case of low water level in the boiler tank, which safeguards the boiler heater. It is essential as it not only avoids spoiling of the samples but also saves the time in Re-testing, as the time is very valuable for launching the product.
Q21. What if the dedicated safety controller fails?
Thermolab chambers are provided with an additional safety thermostat. It is a hydraulic mechanical thermostat to cut off the mains supply in case the temperature overshoots. This thermostat is over and above the dedicated safety controller, which is an electronic controller. The thermostat being mechanical will not affect any component failure due to voltage fluctuation or spikes in the supply. This is provided to have 100% relief and safety from any overshoot problem. It is essential as it not only avoids spoiling of the samples but also saves the time in Re-testing, as the time is very valuable for launching the product.
Q22. What is the sound pressure level (in dB(A) at free field measuring in a distance of 1 m from the front & What is the acoustic power level, in terms if dB (A)?
The acoustic power level around the chamber will be around 40 dB.
Q23. Whether audio / visual alarms are available if set conditions are crossed / not reached?
The chamber has been provided with a dedicated safety controller which will cut off the mains supply in case of overshoot or undershoot of temperature by 5 deg. C. giving audio video alarm.
Q24. How much floor space is required to install a chamber?
Thermolab chamber are specially designed to occupy minimum floor space with vertical structure. Floor space required for the chamber varies as per the model selected. Normally the space required for each chamber is its external size + 2 feet working space around the chamber.
Q25. What is the dimension of door?
The dimension of door depends on the Model chosen which are as follows : Capacity of Chamber Dimension of door L X D X H cms 90 Ltrs 58 X 4 X 50 200 Ltrs 69 X 4 X 76 400 Ltrs 69 X 4 X 122 800 Ltrs 90 X 4 X 136 1000 Ltrs 90X 4 X 168 And for Walk-In Type Stability Chamber the door size is common i.e. 1800 X 800 cms
The dimension of door depends on the Model chosen which are as follows :
And for Walk-In Type Stability Chamber the door size is common i.e. 1800 X 800 cms
Q.26. What is the gross weight of chamber?
The weight varies as per the capacity Capacity of Chamber Gross Weight in KG Without Packing 90 Ltrs 85 200 Ltrs 195 400 Ltrs 220 800 Ltrs 402 1000 Ltrs 470
The weight varies as per the capacity
Q27. What is the overall weight and size of chamber after packing?
The weight and size varies as per the capacity Capacity of Chamber Gross Weight in KG After packing L x D x H cms External dimension after packing L x D x H cms 90 Ltrs 130 68 x 91 x 100 200 Ltrs 295 85 x 125 x 132 400 Ltrs 330 85 x 125 x 180 800 Ltrs 600 105 x 151 x 203 1000 Ltrs 650 105 x 151 x 235
The weight and size varies as per the capacity
Q.28. What is the heat emission behaviour of the chamber, around in the area?
The heat emission around the chamber (compressor / condensor) will be around 60 watts. It is advisable to keep the chamber in a well-ventilated room 'OR' in an air-conditioned room.
Q.29. What is the power supply requirement of a chamber?
The power supply required is 230 V AC 50 Hz single phase Stabilised power supply with MCB fitted for each chamber. The socket should be 5 pins 20-amp plastic socket.
Q.30. What is the current consumption at each of the ICH conditions, separately?
The current consumption of each ICH condition will be 12 amps for each chamber. Any chamber can be used for any conditions.
Q31. What is the water drain system? Pressurized or unpressurized, details?
The drain line should be provided at the ht. of 2" from the floor level. The drain is not pressurized and is by gravity only. The drain line should have ½" nozzle fitted to fit in rubber pipe.
Q32. What is the humidification water used, its pH, conductivity and whether level indication (float control and low water alarm) are available?
The humidification water should be as soft as possible. It is recommended to use DM or Distilled Water supply to the chamber. Also the water supply should be continuous and The humidification system is provided with a low water level cut off so in case of inadequate water supply to the tank the unit will cut off the main contactor giving audio video alarm.
Q33. Why only DM or Distilled water is recommend for the chamber?
The use of DM or Distilled water is recommended to avoid all the scaling on the water heater.
Q34. What is the water consumption at each of the ICH conditions, separately?
The water consumption will vary as per the capacity of the chamber Capacity of Chamber Approx. water consumption per 24 hours 90 Ltrs 7 to 8 ltrs 200 Ltrs 8 to 10 ltrs 400 Ltrs 10 to 12 ltrs 800 Ltrs 13 to 15 ltrs 1000 Ltrs 15 to 17 ltrs
The water consumption will vary as per the capacity of the chamber
Q35. Whether re-circulation of the residues / process - water is possible?
Re-circulation of processed water is not possible.
Q36. Does Thermolab provide Warranty for its Equipment? If "Yes" than what is included in the warranty?
Thermolab provides One year Warranty for each of the Equipment. Thermolab is committed for the Free Service, any part replacement incase of manufacturing defect, Installation, Documentation and Validation during the Warranty Period.
Q37. Does Thermolab install their equipment?
Thermolab is committed for the installation of the equipment, which includes the Training for the end user, validation on site, IQ, OQ, and PQ Documentation of International Standard.
Q38. What do I do to install the Equipment?
Please refer the Installation requirement for the same.
Q39. Are Spares available for the Thermolab Equipment?
Thermolab provides all the necessary Spares as and when required. One can avail the same by just sending the enquiry. It is recommended to keep the necessary spares in case of emergency / breakdown.
Q40. Does Thermolab provide the revalidation and calibration service?
Thermolab provides the Re-Validation and Calibration service after the warranty period is over. To avail the service one can contact our customer service cell.
Q41. Who do I Contact for servicing Thermolab Equipment?
You can contact our Thermolab Customer Service Centers located at different location for the service of the Thermolab Equipment or you can email us at "customerservices@thermolabindia.com " Thermolab is committed for after sales service.
You can contact our Thermolab Customer Service Centers located at different location for the service of the Thermolab Equipment or you can email us at "customerservices@thermolabindia.com
" Thermolab is committed for after sales service.
Q42. Do you undertake the maintenance of the equipment after the warranty period of the equipment is over?
Thermolab is committed to keep the equipment working during warranty period and also after expiry of warranty period. After the warranty period, we offer a complete Annual Maintenance Contract (AMC) assigned to keep the equipment in working condition. The Annual Maintenance Contract (AMC) is done by trained personnel available with the service department. One can avail the service by sending the enquiry for the same (Enquiry Form)
Q43. Is it worth purchasing Thermolab Equipments?
Yes it is "WORTH" as it will give "VALUE FOR YOUR MONEY" in a longer run as compared to the rest and a peace of mind. Any one, who is really serious about his stability studies, will definitely select the Thermolab Equipments.
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