PM Planning / 483

Preventative Maintenance (PM) should be based on a proactive process that looks at the overall health of a chamber.  A robust protocol will help anticipate problems and outages by recording the health of all components.  Execution of the PM protocol should be performed on a routine schedule that is documented in the facility’s SOP’s.  When determining the frequency for the PM, refer to the manufacturer’s recommendation for timing for specific tasks.

Related FDA483/Warning Letter

  1. No written procedure is approved by QA describing Preventative Maintenance tasks and their Frequency for concerning monthly tasks for the walk-In [redacted] RH stability chamber.
  2. No written procedure describing the frequency and explicit maintenance checks to be conducted by the manufacturer of the [redacted] RH stability chamber on a [redacted] basis.
    www.fda.gov

 

A majority of the recently reviewed PM programs, I found those processes only look at minor functional parts such as seals, locks, filters, drains, and internal surfaces.  They did not look at the operations of major components of the system.  This type of PM program is a minimalist approach at maintaining a unit. It does not give an overview of the unit’s health.  It does meet the requirement for a PM process, but with older units, it does not look at the operation of major components.

Related FDA483/Warning Letter

  1. There is no Preventive Maintenance (PM), or PM is inadequate for equipment used in the production or storage of [redacted] Intermediates.

For example:

  1. The PM for the -30C Freezer (#V133) used for product storage is inadequate. During the inspection, the freezer was found with ice needle formation on the ceiling, floor, entrance floor, curtains of the freezer, and inside the open containers used for product container storage.
    www.fda.gov

 

When setting up a robust PM program it should include two sections, a visual inspection of the unit and a physical operations check of the unit.  All checks should be documented and filed in the units equipment file.  Each unit should have its own documentation packet.

The physical portion of a PM should include checking pressure readings on compressors and valves, voltage flow measurements at critical components, cleaning of water boilers, defrosting and flow checks of the drain lines.

Visual inspections should include checking the operation of light switches, locks, door seals, filters, fans and interior surfaces. Visually checking/cleaning of fan blades and cooling coils needs to done.

Documentation should include all pressure readings on the physical section and a Pass/Fail/Completed/Comment statement on the visual section.  Any issues or corrections should be documented in this documentation.  The technician performing the work needs to sign the document as well as the chamber owner.  If it’s not documented, it’s not done.

 

US based Stability Chamber Manufacturer’s PM Scheduling Recommendations

Manufacturer A B C D E F

Maintenance Frequency

3 month basis Daily/

Monthly/

Annually

Depends upon how the facility is used Monthly/

Yearly

Quarterly/

Annually as needed

Every 6 month/

Once a year/

Periodically

Note: Chamber manufacturer described maintenance frequency is defined according to the each component.

 

As you can see above, the maintenance frequency for the US based manufacturer’s recommendations is not standardized.

If you would like to

  • plan a compliant PM program,
  • review and improve your current PM program,
  • confirm your chamber’s manufacturer maintenance frequency and what they recommend,

Feel free to ask us. We can review and improve your PM program.

 

Now, it’s FREE for a limited time for ONE stability chamber diagnostic.

We will analyze your chamber and its malfunction tendency, and get back to you with the results in a PDF file. It takes only 3 business days!

Try it now for your best PM program. It’s FREE!

 

Please contact us inquire@naganoscience.com

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