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Photostability Chamber ICH Stabilty Chamber Climatic Chamber Temperature Chamber Humidity Chamber
Photostability Chamber

Photostability Chamber Validation and Qualification Service

Ellab is a provider of onsite cGMP ICH photostability storage chamber and room validation and qualification services. Photostability chambers are ideal for testing how product behaves when stored in specific light, temperature and humidity set points. These set points represent potential atmospheric conditions during storage and transport. Specifically, photostability test chambers are used to characterize the effect of light on the degradation of the efficacy of the product (photo-degradation). In addition to the two aforementioned parameters, pharmaceutical products may also be sensitive to lighting conditions, meaning that overexposure can negatively affect their stability or shelf-life. ICH guideline Q1B states that “the intrinsic photostability characteristics of new drug substances and products should be evaluated to demonstrate that, as appropriate, light exposure does not result in unacceptable change” to the product or packaging. To provide documented evidence of the products’ photodegredation properties, testing should be done within a photostability chamber. 

Photostability Chamber Qualification
The purpose of photostability chamber qualification is to ensure that there is uniformity over the usable area of exposure so that product testing results are not affected by their location within the testing chamber. The parameters included in the qualification are ultraviolet radiation (UV-A), illuminance (or white light intensity measured in kilo-lux) and temperature. Temperature can have a significant impact on the lighting parameters and its precise control is important to the process.

High Level of Execution and Quality Documentation
These areas are critical as ICH photostability chambers & rooms are used to store and test your active pharmaceutical ingredients (API), medicinal products (Part A), existing active pharmaceutical ingredients and products (Part B) and medical devices. You can expect a high level of execution, quality documentation, and the expertise you deserve. Be confident that we will be your Subject Matter Experts (SME) to rely upon.

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Typical Set Points for ICH PhotoStability Chambers & Rooms

Temperature & Humidity & Light: Thermal & Humidity Stability with Light Study: Typical acceptance criteria is ±2C and ±5% RH

  • 21°C/45% RH (ICH Climatic Zone 1, Long-Term Storage)
  • 25°C/25% RH (Semi-Permeable, Aqueous-Based Products)
  • 25°C/40% RH (Semi-Permeable, Aqueous-Based Products)
  • 25°C/60% RH (ICH Climatic Zone II, Long-Term Storage)
  • 25°C/80% RH
  • 30°C/35% RH (ICH Climatic Zone III, Long-Term Storage, Semi-Permeable, Aqueous-Based Products)
  • 30°C/65% RH (ICH Climatic Zone IV, Long-Term & Intermediate Storage, Semi-Permeable, Aqueous-Based Products)
  • 30°C/75% RH (ICH Climatic Zone IVb, Long-Term Storage)
  • 40°C/not more than (NMT) 25%RH (Semi-Permeable, Aqueous-Based Products)
  • 40°C/25% RH (Semi-Permeable, Aqueous-Based Products
  • 40°C/75% RH (ICH Accelerated Storage Condition)
  • 50°C/10% RH
  • 50°C/Ambient RH
  • 60°C/Ambient RH

Temperature, Humidity, Light

Photostability Testing: This environmental parameter may be added to any of the above conditions. 

ICH Stabilty Chamber

ICH Stability Chamber Validation and Qualification Service

Ellab is a provider of onsite cGMP ICH stability chamber validation and qualification services. Storage areas as critical as ICH Stability Chambers and Rooms are used to store and test your active pharmaceutical ingredients (API), medicinal products (Part A), existing active pharmaceutical ingredients and products (Part B) and medical devices. ICH stability chambers come under heavy scrutiny since they are used to test the stability of API and medical products over time as they are exposed to temperature, humidity and light. The information determined by this storage testing is used to determine and verify the shelf life of these items in various climactic zones around the world. This means that there are specific storage instructions that need to be complied with.

Patient Safety
Stability can also be considered for the refrigeration and freezing of the API, sample, or product. All of this is to ensure that there is a known period of time in which there is a high confidence that the product has not degraded ensuring that the patient is safe. This also ensures that there is a known time where the API and medical devices are still stable and carry the necessary quality, safety, and efficacy. These should all be considerations in the shelf life acceptance criteria. Typical environmental conditions verified in controlled storage areas include thermal (temperature) uniformity mapping, Relative Humidity (RH%), Carbon Dioxide (CO2), rotation and light.

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ICH Alcohol Aqueous Stability Chamber Validation and Qualification Service

ICH Alcohol Stability Chambers & Rooms used for aqueous-based products packaged in semi-permeable containers being evaluated for potential water loss are critical. Additional concerns are physical, chemical, biological and microbiological stability criteria. The goal is to show that aqueous-based medicinal products stored in semi-permeable containers can withstand low relative humidity environments. This information is used to determine and verify the shelf life of these items through various climactic zones around the world, and in particular focusing on low humidity environments to ensure that the semi-permeable containers do not allow water loss. Other studies are performed with comparable approaches for non-aqueous, solvent-based products. This means that there are specific storage instructions that need to be complied with. Stability can also be considered for the refrigeration and freezing of the API, sample or product. All of this is to ensure that there is a known period of time in which there is a high confidence that the product has not degraded ensuring that the patient is safe, and that there is a known time where the API and medical devices are still stable and carry the necessary quality, safety, and efficacy. These should all be considerations in the shelf life acceptance criteria.

Climatic Chamber

Climatic Chamber Validation and Qualification

Ellab is a provider of onsite cGMP laboratory climatic chamber validation and qualification services, which include temperature and humidity mapping. A laboratory climatic chamber is an environmental chamber used to store in-process product samples for ongoing quality control studies.

Storage of Biopharmaceutical Materials
Climatic chambers are used to store a wide variety of biopharmaceutical materials. These climatic chambers provide temperature and humidity stability and uniformity throughout the entire cabinet providing an optimal storage environment.

Different types of climatic chambers are: laboratory/pharmaceutical, blood bank/plasma, chromatography laboratory & scientific temperature chamber, sliding glass door/pass-thru temperature chamber, flammable storage/explosion resistant temperature chamber. In the life science industry, there can be both reach-in and walk-in climatic chambers used at any laboratory.

Environmental Chamber Temperature Mapping
In highly regulated environments that need to comply with current Good Manufacturing Practices (cGMP) or current Good Laboratory Practices (cGLP) it is often required to map your environmental chambers to ensure that your product or sample is in fact in the desired environmental conditions.

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Qualification Process of Climatic Chambers

The purpose of qualification is to ensure that the equipment or climatic chamber is properly installed, working correctly, and producing the specified performance outcomes under routine operating conditions. A qualification requires a sufficient number of electronic data logging monitors to ensure that qualification activities can be carried out correctly. Furthermore, suitable computer equipment and software is needed to store and analyze the data. The data loggers should have the following characteristics:

  • Be appropriate for the specific task and the intended operating temperature & humidity range.
  • Provide a reliable and continuous reliable record of time and temperature & humidity data.
  • Have an appropriate temperature range so that all anticipated temperature extremes can be recorded.
  • Have a user-programmable data sampling period allowing time intervals to be set in the range from one minute or higher and with sufficient memory for the intended length of the study and the chosen recording interval.
  • Have a NIST-traceable 3-point calibration certificate and have a guaranteed error of no more than ±0.5°C at each calibration point.
  • Recorded time-temperature & humidity data should be downloadable to a computer data acquisition system for subsequent analysis.
  • Data storage and analytical software should comply with applicable regulatory requirements
Temperature Chamber

Temperature Chamber Validation and Qualification Service

Ellab is a provider of onsite cGMP laboratory temperature chamber validation and qualification services, which often include temperature mapping. A laboratory temperature chamber is an environmental chamber used to store in-process product samples for ongoing quality control studies. Temperature chambers are used to store a wide variety of biopharmaceutical materials by providing temperature stability and uniformity throughout the entire cabinet providing an optimal storage temperature environment. Common versions of temperature chambers include: laboratory/pharmaceutical, blood bank/plasma, chromatography laboratory & scientific temperature chamber, sliding glass door/pass-thru temperature chamber and flammable storage/explosion resistant temperature chamber. In the life science industry there can be both reach-in and walk-in temperature chambers used at any laboratory. 

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Qualification Process of Temperature Chambers

The purpose of qualification is to ensure that the equipment or temperature chamber is properly installed, works correctly and produces the specified performance outcomes under routine operating conditions. A qualification requires a sufficient number of electronic data logging monitors to ensure that qualification activities can be carried out correctly. Furthermore, suitable computer equipment and software is needed to store and analyze the data. The data loggers should have the following characteristics:

  • Be appropriate for the specific task and the intended operating temperature range
  • Provide a reliable and continuous reliable record of time and temperature data
  • Have an appropriate temperature range so that all anticipated temperature extremes can be recorded.
  • Have a user-programmable data sampling period allowing time intervals to be set in the range from one minute or higher and with sufficient memory for the intended length of the study and the chosen recording interval
  • Have a NIST-traceable 3-point calibration certificate and have a guaranteed error of no more than ±0.5°C at each calibration point.
  • Recorded time-temperature data should be downloadable to a computer data acquisition system for subsequent analysis.
  • Data storage and analytical software should comply with applicable regulatory requirements such as 21 CFR Part 11.
Humidity Chamber

Humidity Chamber Validation and Qualification

Ellab is a provider of onsite cGMP laboratory humidity chamber validation and qualification services, which often includes temperature and humidty mapping. A laboratory humidity chamber is an environmental chamber used store in-process product samples for ongoing quality control studies. Humidity chambers are used to store a wide variety of biopharmaceutical materials. These humidity chambers provide temperature & humidity stability and uniformity throughout the entire cabinet providing an optimal storage temperature & humidity environment. In the life science industry, there can be both reach-in and walk-in humidity chambers used at any laboratory. Thus, as cGMP equipment, they must be qualified. 

Get a Quote
Qualification Process of Humidity Chambers

The purpose of qualification is to ensure that the equipment or humidity chamber is properly installed, working correctly and producing the specified performance outcomes under routine operating conditions. A qualification requires a sufficient number of electronic data logging monitors to ensure that qualification activities can be carried out correctly. Furthermore, suitable computer equipment and software is needed to store and analyze the data. The data loggers should have the following characteristics:

  • Be appropriate for the specific task and the intended operating temperature range
  • Provide a reliable and continuous reliable record of time and temperature data
  • Have an appropriate temperature & humidity range so that all anticipated temperature & humidity extremes can be recorded.
  • Have a user-programmable data sampling period allowing time intervals to be set in the range from one minute or higher and with sufficient memory for the intended length of the study and the chosen recording interval
  • Have a NIST-traceable 3-point calibration certificate and have a guaranteed error of no more than ±0.5°C at each calibration point.
  • Recorded time-temperature data should be downloadable to a computer data acquisition system for subsequent analysis.
  • Data storage and analytical software should comply with applicable regulatory requirements
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