| What are the water requirements for the chambers? |
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Please see attached information:
Chamber Water Requirements |
| Related Models: 6010, 6020, 6025, 6030 |
Updated: 11/13/2009 | |
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| What is Validation/Qualification and when is it required? |
| Typically, one would Qualify equipment, but Validate a process. Validation/Qualification is the act of providing documented evidence that the installed equipment or systems perform as specified during the design phase and meets the specifications of the manufacturer, the owner, and applicable regulations. The FDA and EU requirement to illustrate that manufacturing equipment, software, utilities, or processes function as specified. Validation/Qualification is not an option; it is a necessity for any product being manufactured under cGMP (current Good Manufacturing Practice) guidelines or equivalent. |
| Related Models: 6010, 6020, 6025, 6030 |
Updated: 11/13/2009 | |
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| What is an Operational, and Performance Validation/Qualification and how does it differ from the equipment manufacturer's installation? |
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IQ: documenting the as-installed state of the equipment or system in respect to engineering specifications, engineering drawings, utilities, supporting documentation, etc.
OQ: documenting that the equipment or system operates as expected using "black box testing". Black Box testing can be defined as testing each component of a system individually. In addition, all critical functions and alarms are tested for conformance.
PQ: documenting that the entire integrated equipment or system performs as expected and meets all client specified acceptance criteria.
Validation/Qualification is more elaborate than Installation. The IQ takes the installation several steps further. Typically, the manufacturer's installation can be defined as minor commissioning, where the equipment or system is set up, turned on, and basic operation verified. No worst case, or functionality testing is performed. |
| Related Models: 6010, 6020, 6025, 6030 |
Updated: 11/13/09 | |
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| Do Caron's chambers meet the requirements of 21 CFR Part 11? |
| With all environmental test chambers, we offer circular chart recorders to monitor and record testing conditions. The paper chart recorders do not fall under the jurisdiction of 21 CFR Part 11. In addition to the chart recorder, we offer controllers with communications connections on them. This technique is 21 CFR Part 11 compliant if the customer uses them in conjunction with third-party software that is compliant. Software purchased through CARON is not 21 CFR Part 11 compliant. |
| Related Models: 6010, 6020, 6025, 6030 |
Updated: 11/13/09 | |
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| What are the environmental chamber’s shelves made of and how much weight can they support? |
| The standard shelves in the 10 and 25 cu. ft. chambers are stainless steel, perforated shelves. The 30 cu. ft. Environmental Chambers come standard with stainless steel, wire rod shelves. The model 6010 chamber comes with 3 shelves and can hold 40 pounds per shelf. The model 6020 and 6025 come standard with four shelves that holds up to 50 pounds per shelf. The model 6030 chamber comes with 5 shelves and can hold 50 pounds per shelf.
Solid, stainless steel shelves and other additional shelves are also available. (Consult factory for details) |
| Related Models: 6010, 6020, 6025, 6030 |
Updated: 11/13/09 | |
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| The facility where I will be using the chamber does not have access to a water supply or drain; can I still use the chamber? |
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Caron offers a condensate recirculating system (CRSY102) that works as a water delivery and recovery system to the chamber for this very purpose. Clean, filtered water is supplied to the chamber’s humidity injection system. The condensation that forms in the chamber is collected and recycled back into the condensate recirculating system.
In an environmentally conscience world, the condensate re-circulating system assists the environment by filtering and reusing water.
Caron recommends using distilled or deionized water with resistivity between 0.05 and 1.0 Mega Ohmn-cm and pH above 6.5. |
| Related Models: 6010, 6020, 6025, 6030 |
Updated: 11/13/09 | |
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| At our facility we place high importance on preserving our natural resources, when using the chamber, how can we eliminate wasting excess water? |
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Caron offers a condensate recirculating system that works as a water delivery and recovery system to the chamber as an alternate to using an in-house supply of distilled or demineralized water. This system, CRYS102, uses recycled water from the chamber by collecting and recycling the condensation that forms in the chamber. As the chamber calls for humidity clean, filtered water is supplied to the humidity injection system. Our natural resources are precious and Caron offers this option to eliminate wasting unnecessary water supplies.
Caron recommends using distilled or deionized water with resistivity between 0.05 and 1.0 Mega Ohmn-cm and pH above 6.5. |
| Related Models: 6010, 6020, 6025, 6030 |
Updated: 11/13/09 | |
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| What type of water must be used with the Caron chambers? |
Caron recommends using distilled or deionized water with resistivity between 0.05 and 1.0 Mega Ohmn-cm and pH above 6.5. Using water outside this range may void parts of the warranty.
Chamber Water Chart |
| Related Models: 6010, 6020, 6025, 6030 |
Updated: 11/13/09 | |
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| I have a PC and want to control or monitor the chamber from that PC, is this possible? |
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An optional RS-485 communications interface can be purchased to provide data logging, set-up and operation from a PC (DLUX301 and COMM103)
Caron also offers optional computer software and chart recorders for your data logging requirements (SFTW 102 and SFTW 103). The software can be used for real time operation, set-up, and data logging and is very user friendly. |
| Related Models: 6010, 6020, 6025, 6030 |
Posted: 11/13/03 | |
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| Are there any restrictions to where I locate a chamber within my facility? |
| The Caron chamber must be located in a dry, clean and level area. Allow a 4" clearance from the back and top of the chamber for proper air circulation and ease of installation. Locate the chamber in an area out of direct sunlight and away from heating and cooling ducts. |
| Related Models: 6010, 6020, 6025, 6030 |
Posted: 11/13/03 | |
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| What are the electrical requirements for the chamber? |
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The 10 cu. ft., model 6010's, requirements are as follows:
6010-1 115V, 60Hz, 12A FLA Plug Connection: NEMA 5-15
6010-2 230V, 60Hz, 8A FLA Plug Connection: NEMA 6-15
6010-3 230V, 50Hz, 6A FLA Plug Connection: CEE 7/7
The 25 cu. ft., model 6020 and 6025's, requirements are as follows:
6020/6025-1 115V, 60Hz, 16A FLA Plug Connection: NEMA 5-20
6020/6025-2 230v, 60hZ, 10A FLA Plug Connection: NEMA 6-15
6020/6025-3 230V, 50Hz, 8A FLA Plug Connection: CEE 7/7 |
| Related Models: 6010, 6020, 6025 |
Updated: 11/13/09 | |
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| I need to simulate day and night conditions. Can this be done with your chambers? |
| Yes, Caron offers a lighting package for the chamber (LGHT102, LGHT301, LGHT303). With this option the operator can simulate Day/Night testing by switching between two set points on a 24 hour timer. A switch will turn the light banks on and off simultaneously as well as operate the two setpoint temperature system. During the operation of the Diurnal lighting system a second setpoint can be set in both the temperature and humidity controllers. This second setpoint will be used as the day setpoint (lights on). |
| Related Models: 6010, 6020, 6025, 6030 |
Updated: 11/13/09 | |
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| How does the humidity system work and what humidity levels can I reach? |
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The bi-modal humidification system allows for independent humidification and dehumidification. The humidity injection system utilizes atomizers to inject moisture into the chamber to achieve humidity levels from 20% to 98% RH. Dehumidification is accomplished by a refrigeration coil.
Lower humidity levels are attainable with the use of the dryer package option designed to extend the operational limits of the chamber to its minimum humidity control point of 2% RH (DRYR109 and DRYR301). The dryer package uses 90 to 100 psig compressed air to operate.
Click here to refer to the Chamber Performance Chart |
| Related Models: 6010, 6020, 6025, 6030 |
Updated: 11/13/09 | |
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| I need to use the chamber to perform a variety of tests which will require different temperature and humidity setting for each test; can the Caron chamber perform all of my required tests? |
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The Chamber Performance Chart shows the standard temperature and humidity operating range of the chamber. If your temperature and humidity requirements fall below the standard range, the dryer package option can help you reach lower humidity levels.
Lower humidity levels are attainable with the use of the dryer package option which was designed to extend the operational limits of the chamber to its minimum humidity control point of 2% RH. The dryer package uses 90 to 100 psig compressed air to operate. Refer to Chamber Performance Chart.
Caron offers a defrost package option to allow operation of the chambers below 5° C. This system will prevent frosting of the condensing coil by using a pre-set defrost timer that cycles every 24 hours with defrost duration adjusted for 15 minutes. Refer to Chamber Performance Chart. |
| Related Models: 6010, 6020, 6025, 6030 |
Posted: 11/13/09 | |
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| What type of data logging options do you offer with the Caron chamber? |
| As accessories, Caron offers computer software and chart recorders for your data logging requirements. The software can be used for real time operation, set-up, and data logging and is very user friendly. A two-pen circular chart recorder provides highly accurate temperature and humidity recordings for 24 hour to 7-day operation. |
| Related Models: 6010, 6020, 6025, 6030 |
Posted: 11/13/09 | |
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| I need to perform multiple stability tests at the same time, but have limited space in my facility, what can I do? |
| The 10 cu. ft. (model 6010) chambers provide 10 cu. ft. of workspace per unit and can be stacked two high to eliminate wasted bench top space. |
| Related Model: 6010 |
Updated: 11/13/09 | |
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| The tests I will be running in the chamber require that I ramp & soak to a number of different temperature and humidity set points throughout the test; can this be done? |
| As an option, CARON offers a controller that will allow the operator to have ramp & soak capabilities (CNTR 113, DLUX301) |
| Related Models: 6010, 6020, 6025, 6030 |
Updated: 11/13/09 | |
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| Do your chambers meet ICH and WHO guidelines for Stability and/or Photostability? |
| Yes. Caron’s chambers are designed specifically to meet WHO and ICH guidelines for general stability testing of new drugs substances and products Q1A(R) long-term and accelerated refrigerator testing, and Caron also manufactures a chamber for photostability testing designed in accordance with ICH Q1B guidelines. (Click here to learn more about our Photostability Chamber.) |
| Related Models: 6010, 6020, 6030 |
Updated: 11/13/09 | |
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