| Why is ICH Q1B Option 2 preferred over Option 1? |
| Option 2 is the only lighting method that allows testing to the exact confirmatory requirements. It also provides added flexibility during forced degradation studies. See white paper. |
| Related Models: 6540-1, 6540-2, 6540-3, 6545-1, 6545-2, 6545-3 |
Posted: 05/09/06 | |
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| How long will the lamps last and where can replacements be purchased? |
| For optimal performance, CARON recommends replacing the lamps every 2000 hours. Lamp replacement sets can be ordered through CARON. |
| Related Models: 6540-1, 6540-2, 6540-3, 6545-1, 6545-2, 6545-3 |
Posted: 05/09/06 | |
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| What are the water requirements for the chambers? |
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Please see attached information:
Chamber Water Specifications |
| Related Models: 6510, 6515, 6530, 6535, 6540-1, 6540-2, 6540-3, 6545-1, 6545-2, 6545-3 |
Posted: 09/27/05 | |
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| What is Validation/Qualification? |
| 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. |
| Related Models: 6510, 6515, 6530, 6540-1, 6540-2, 6540-3, 6545-1 (formerly 6545A), 6545-2, 6545-3 (formerly 6545E) |
Posted: 09/13/05 | |
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| When is Validation/Qualification required? |
| 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: 6510, 6515, 6530, 6535, 6540-1, 6540-2, 6540-3, 6545-1, 6545-2, 6545-3 |
Posted: 09/13/05 | |
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| What is an Installation, Operational, and Performance Validation/Qualification? |
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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 criteria. |
| Related Models: 6510, 6515, 6530, 6535, 6540-1, 6540-2, 6540-3, 6545-1, 6545-2, 6545-3 |
Posted: 09/13/05 | |
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| How does the equipment manufacturer's Installation differ from Validation/Qualification? |
| 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: 6510, 6515, 6530, 6535, 6540A, 6540E, 6545A, 6545E |
Posted: 09/13/05 | |
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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: 6510, 6515, 6530, 6535, 6540-1, 6540-2, 6540-3, 6545-1, 6545-2, 6545-3 |
Posted: 05/05/05 | |
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| What are the ICH and FDA requirements for photostability testing? |
| The FDA requires that all new drugs be tested for shelf life by exposing drugs to simulated sunlight. Drugs must be exposed to at least 1.2 million lux-hours of visible light and 200 W-Hr/m2 UVA light. |
| Related Models: 6510, 6515, 6530, 6535, 6540-1, 6540-2, 6540-3, 6545-1, 6545-2, 6545-3 |
Posted: 11/13/03 | |
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| How is light intensity and exposure measured? |
| CARON measures light intensity using a calibrated radiometer. Photostability testing requires the measurement of light. Visible light intensity is measured in terms of Lux and exposure level in Lux-hr. UVA light intensity is measured in W/m2 and exposure level in W-hr/m2. |
| Related Models: 6510, 6515, 6530, 6535, 6540-1, 6540-2, 6540-3, 6545-1, 6545-2, 6545-3 |
Posted: 11/13/03 | |
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| Can I record the light intensity using a chart recorder? |
| Absolutely, CARON offers a chart recorder that will record continuous light intensity along with temperature and humidity on a 12” circular chart recorder. With this recorder you can record either Visible or UVA light intensity. |
| Related Models: 6510, 6515, 6530, 6535, 6540-1, 6540-2, 6540-3, 6545-1, 6545-2, 6545-3 |
Posted: 11/13/03 | |
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| When looking over the ICH guidelines for Photostability testing, I noticed an Option 1 and Option 2. What is the difference in the two options? |
| According to Option 1, near UV and visible light testing is performed simultaneously using fluorescent D65 lights. Option 2 uses two different lamp types, fluorescent cool white lamps for VIS exposure and near UV fluorescent lamps (320nm to 400 nm) for UVA exposure. The VIS and UVA testing can be done simultaneously or sequential. |
| Related Models: 6510, 6515, 6530, 6535, 6540-1, 6540-2, 6540-3, 6545-1, 6545-2, 6545-3 |
Posted: 11/13/03 | |
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| Do CARON’s Photostability Chambers offer Option 1 or Option 2 of the ICH Guidelines for Photostability testing? |
| CARON’s standard 6500 series photostability chambers are configured to Option 1. The 6540 series photostability chambers are configured to Option 2. |
| Related Models: 6510, 6515, 6530, 6535, 6540-1, 6540-2, 6540-3, 6545-1, 6545-2, 6545-3 |
Posted: 11/13/03 | |
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| Do you offer any type of validation support for the Photostability Chambers? |
CARON offers an Installation and Operation Qualification (IQ/OQ) protocol for all Photostability Chambers (VLD-650 for 6500 Series and VLD-640 for 6540 Series). This information outlines the procedure for chamber validation, but does not include the actual on-site validation.
VLD-651 (for 6500 Series) and VLD-641 (for 6540 Series) provides full on-site IQ/OQ/PQ validation and includes the protocol listed above. |
| Related Models: 6510, 6515, 6530, 6535, 6540-1, 6540-2, 6540-3, 6545-1, 6545-2, 6545-3 |
Posted: 11/13/03 | |
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| What are the electrical requirements of the 6500 Series Photostability Chambers? |
For electrical requirements for the 6500 Series Photostability Chambers - see manual.
For electrical requirements for the 6540 Series Photostability Chambers - see manual. |
| Related Models: 6510, 6515, 6530, 6535, 6540-1, 6540-2, 6540-3, 6545-1, 6545-2, 6545-3 |
Posted: 11/13/03 | |
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| Do your Photostability Chambers also have humidity capabilities? |
| Yes, Models 6515 and 6535 Photostability Chambers provide humidity with a range from 30 to 75% RH. Models 6545-1, 6545-2 & 6545-3 Photostability chambers provide humidity with a range from 40 to 70% RH. |
| Related Models: 6515, 6535, 6545-1, 6545-2, 6545-3 |
Posted: 11/13/03 | |
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| What does ICH mean? |
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The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is a unique project that brings together the regulatory authorities of Europe, Japan and the United States and experts from the pharmaceutical industry in the three regions to discuss scientific and technical aspects of product registration.
The purpose is to make recommendations on ways to achieve greater harmonisation in the interpretation and application of technical guidelines and requirements for product registration in order to reduce or obviate the need to duplicate the testing carried out during the research and development of new medicines. The objective of such harmonisation is a more economical use of human, animal and material resources, and the elimination of unnecessary delay in the global development and availability of new medicines whilst maintaining safeguards on quality, safety and efficacy, and regulatory obligations to protect public health. This Mission is embodied in the Terms of Reference of ICH.
For more information, here is a link to the ICH website: www.ifpma.org/ich1.html |
| Related Models: 6010, 6030, 6510, 6515, 6530, 6535, 6540-1, 6540-2, 6540-3, 6545-1, 6545-2, 6545-3 |
Posted: 11/13/03 | |
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