8 Steps to Mapping/Validating a Chamber - Vaisala

1 / APPLICATION NOTE. 8 Steps to Validating/Mapping a Chamber Validation in 8 Steps Step 1. Write a plan Step 2. Check equipment &. documentation Step 3. Confirm device operation Step 4. Set up the data loggers Step 5. Place the data loggers Periodic mapping of conditions within environmental chambers is Step 6. critical for compliance in FDA-regulated applications, where validation Periodically check the progress of conditions such as temperature, and sometimes humidity, is Step 7. mandated. (1, 2, 3, 4, 5) This application note recommends some options Retrieve and store the data to help meet cGMP requirements for validation projects. Note: we refer Step 8. to probes, sensors, data loggers interchangeably within this application Report the findings note. These are broad guidelines only, and most recommendations are based upon using data loggers as the sensing device.

2 Step 1 many regulatory bodies mandate within a Chamber (with the exception Write a Validation Plan temperature mapping of controlled of very small bench-top applications). spaces, they do not specify any This comprises two layers of four First, define the objective of the particular method so the onus is loggers, one near each corner and one validation in writing, creating an therefore on us to document and logger in the center. Or, outline of the methods to be used, provide justification for our mapping and list any anticipated barriers. In procedures. Fifteen (15): three layers of four most cases, these three items will form loggers one near each corner and one the bulk of the validation protocol. How many data points do you need logger in the center. Below there are several questions, to monitor/map?

3 The answers to which will ideally be in This number will vary based on Or, four or five loggers per shelf. writing as part of the Validation plan. a number of factors, including environment, temperature/RH range, Where will each data logger What regulations and application, but a typical number of be placed? requirements must you comply with? units used to map small chambers can Spacing the loggers in an evenly Start with a review of those listed in include: distributed grid is recommended, the quality guidelines of the facility however, it's also important to monitor ( CFRs 210, 211, etc) and scan for Nine (9): In most cases, this is the the worst-case locations within a recent changes or updates. Although bare minimum of sample locations Chamber for heat-loss and/or air movement.

4 Monitoring the corners of How long will the mapping study be? mapping study, and a measurement the Chamber and near any openings/ Again, it varies and justification may interval of 15-30 seconds. With the pass-throughs will cover most worst- be required. Typical study lengths Chamber temperature stabilized and case locations; however shelving/ are 24, 48, or 72 hours. Occasionally data loggers recording data, the racking within the Chamber may facilities map for one week, one month, door to the Chamber is opened for require the identification of additional or even longer. For laboratory scale a period of time that is typical for worst-case locations. Place a sensor chambers and walk-in chambers, 24- normal operation of the Chamber at or near the control sensor for the 72 hours can be sufficient.

5 However (1 minute for laboratory scale temperature control unit, and any for larger scale projects ( a chambers, up to 5 minutes for large alarm sensors within the Chamber . temperature controlled warehouse) walk-in chambers used in shipping/. where the temperature can be receiving areas) and then closed. What is the Chamber load? influenced by the temperature outside Data collection continues until the Will the mapping take place with the the facility, longer studies may be Chamber returns to specified Chamber empty, as for an Operation required. Larger scale chambers may operating range. This test shows Qualification (OQ), or full of product, also require studies during summer that product temperatures are not as for a Performance Qualification and winter months depending on the adversely affected during normal (PQ)?

6 For most pharmaceutical and seasonal temperature variations at the operation of the Chamber . biotechnical applications, both tests facility's location. are important. Consider how OQ Insulation Thermal Conductivity/. and PQ might affect the process. What will the duration be? Temperature Change Study . As well, some regulatory bodies(2) Pre-determining a test schedule will This study also uses the same setup mandate the use of maximum and allow the validation technician to set as the mapping study, with the same minimum loads during the validation all data loggers to simultaneously start measurement interval of the process. An empty Chamber can be and stop collecting data at the same mapping study. With the Chamber considered the minimum load and is time.

7 Temperature stabilized and data usually the worst-case for temperature loggers recording data, power is fluctuations within the Chamber . How frequently will testing removed from the temperature be repeated? control unit for the Chamber . Data is Tracking air temperature inside While some industries only require an usually collected for a 12-hour the Chamber Vs. interior product initial qualification, some require that period. This study provides temperatures : temperature mapping be repeated on a information on how long the Tracking interior product regular basis. Once again, review any Chamber remains within the temperatures , such as the temperature applicable regulations and be sure to specified operating range in the inside a solution bottle, is sometimes document the intended test frequency event of a power failure.

8 Data considered more meaningful as it in the validation plan/protocol. from this study can be used to help insulates the data against minor Generally, while the initial qualification determine if product is adversely disturbances such as periodic door will usually include mapping of the affected following a power failure, openings and closings. empty Chamber and the loaded as well as for developing procedures Chamber , subsequent re-qualifications for transferring product to a What parameters will you measure? only require mapping of the loaded different Chamber /facility in the Should the Chamber be mapped for Chamber . event of failure. temperature only? Or temperature and relative humidity? If there is any What additional tests may be useful? Many of these questions may already plan to store products with humidity In most cases regulatory bodies be answered by past practices, sensitivities, then the Chamber should only require validation of an empty protocols, or SOPs.

9 Be mapped for relative humidity as Chamber and a loaded Chamber . well as temperature. However, other types of tests may provide valuable information. Two How frequently will take readings? common tests that many companies Typical sample rates are once every find useful are: minute or once every five minutes, however, as with most other aspects Temperature Recovery Study This of validation, be prepared to justify study uses the same number of sample rate and include that rationale probes in the same locations as the in the plan and/or protocol. Step 2 Step 3 the start/stop times will eliminate the Check Equipment & Confirm Device Operation collection of extraneous data;. Documentation Check for damage before use. The facility Set a sample interval that is In a GMP environment it is essential to may have an SOP that covers this type appropriate to the application.

10 Again, ensure that the equipment being used to of check. If not, there are several ways to a typical safe sample interval might perform any Chamber qualification is not ensure proper operation. For example, be once per minute;. only appropriate for the job but in good if the data loggers have been stored Set a meaningful data logger working order. together and set to wrap (take readings description for each of the data Two considerations: on a continuous sliding window basis), loggers. For example, each data logger simply transfer the information collected might have an ID that describes its Have the loggers been validated for this by the data loggers to a PC and compare location in the Chamber . type of application? Ideally the the readings from the various data equipment manufacturer will provide an IQ/OQ validation protocol expressly loggers.