Chamber Cleaning / 483

An overlooked part of the chamber maintenance is the cleaning of the chambers and is not being considered as a critical part of their operation.  This lack of attention can lead to 483’s being issued by auditors.

Related FDA483/Warning Letter

6, Initial qualification and routine calibration, maintenance and cleaning of automatic, mechanical, and electronic. Equipment is not performed according to a written program designed to assure proper performance

The interior surfaces of a chamber need to be cleaned on a regular schedule to help prevent possible safety and contamination issues.  Safety and Quality should be a combined number one goal when storing samples.  Contamination not only affects the samples integrity, but it can be tracked back into the facility and affect the health of personnel not accessing the chamber.  Contaminations can be transferred from the chambers to the labs in extreme cases, and affect the results of testing.  Chambers can be the perfect breeding environment for fungus and molds due to temperatures and humidity.

The documentation of this process should detail the Who, What and When of the process.   This process needs to be written in a clear and concise manner, whether it is in a SOP on its own or in in the SOP describing maintenance.  It should include any special cleaning needs such as deactivation agents for specific compounds.  This process needs to be documented in the logbooks and on the equipment maintenance forms for each pieces of equipment.  In short, the chambers should be cleaner than the office area of the CEO

Related FDA483/Warning Letter

II . Written procedures for cleaning and maintenance fail to include assignment of’ responsibility, maintenance and cleaning schedules, and a description in sufficient detail of methods, equipment and materials ls used.


The Who. This section defines the roles and responsibilities of the groups involved.  The process needs to be coordinated by the Stability group not the Housekeeping group.   It does not mean Stability has to do the work, but schedule the work into their schedule.  This coordination is needed to document the work done, answer any alarms generated, ensure that sample integrity is not compromised, and provide security.  When bringing in a contractor, the contractor should be on the Approved Vendor List (AVL).  Personnel who are doing the cleaning should be trained in the handling of chemicals they are using.

The What. This is a listing of the approved solutions or products used on the chamber surfaces. A listing of all allowable solutions should be incorporated in the SOP.  This listing needs to be checked with the group performing the cleaning before they start a cleaning cycle in the chamber(s) to make sure they are using allowable products.  The SOP needs to be updated before the work is started, or an exception needs to be written to allow the use.  All solutions and compounds should be checked to make sure they are compatible with chamber surfaces, do not generate any toxic fumes during or after use, which my contaminate samples or affect personnel.  Products should be rated for the conditions they are being used in.  This listing is a reference to any exception investigations to help rule out contamination issues.

Related FDA483/Warning Letter

  1. b) Household bleach was replaced with non-sterile as the cleaning agent for daily mopping of tile floor in the clean room without evaluating the suitability as a daily cleaning agent for vinyl flooring

The When.  This portion of the SOP should define the schedule of cleaning, specifically the sweeping, mopping of floors and cleaning of surfaces.  This discussion should explain the shutdown of extreme chambers and address allowable down times and recovery times. There should be a discussion on the movement of samples, if condition changes are anticipated to cause an impact to samples.  A matrix helps visualize the process frequency and helps define schedule points.  An exception statement should be added to describe an “as needed” cleaning instance which may not be in sequence as described in the matrix.  This type of cleaning may be cause by a spill, broken sample or maintenance repair.

Related FDA483/Warning Letter

  1. a) After the initiation of the inspection, sponge mops for the clean room floors were replaced with a mop equipped with replaceable nonshedding covers; however , written procedures have not been written and established to describe proper mopping practices and frequency to replace the c“.

Documentation for each chamber should include the start, description of work performed, reference to product used review, completion of work and any outages generated during the cleaning.  If a chamber needs to be taken out of service for cleaning, this needs to be documented along with the documentation of sample movement.  This documentation should be logged into the equipment log and the detailed maintenance form should be filed in the equipment file.


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One comment on “Chamber Cleaning / 483

  1. Myriam Rodriguez

    February 5, 2018 at 19:49 Reply

    Hi could you describe what’s the proper mopping practice for cleaning stability chambers when performing minor and major cleaning

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