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Warehouse Environment Control at Medical Devices Distribution

Maintaining a stable climate in storage facilities is critical for product integrity. This guide outlines the essential protocols for environment control, specifically focusing on temperature and humidity monitoring within a warehouse setting.

Warehouse Environment Control at Medical Devices Distribution

1. Purpose of Environment Control

The primary objective of this procedure is to establish a rigorous monitoring system for temperature and humidity. Effective environment control prevents thermal deviation, ensuring that sensitive products remain within their specified safety margins and maintain their shelf life.

2. Scope

This protocol applies strictly to all designated warehouse storage areas, including receiving docks and long-term storage zones where climate-sensitive goods are held.

3. Roles and Responsibilities

To ensure the success of our environment control strategy, the following roles are defined:

RoleResponsibility
Warehouse DepartmentResponsible for the day-to-day execution and compliance of all monitoring procedures.
Quality AssuranceResponsible for auditing log sheets and approving corrective actions.

4. Operational Procedures for Climate Monitoring

Effective environment control relies on consistent data collection and rapid response to fluctuations.

  • Standard Storage Parameters: For normal products, the warehouse must maintain a temperature between 25°C – 30°C and a Relative Humidity (RH) of 65% ± 5%.
  • Monitoring Frequency: Temperature and humidity levels must be checked and recorded three times daily to capture fluctuations across different shifts.
  • Documentation: All data must be entered into the official log book/sheet. Each entry must include:

    • Exact date and time of the reading.
    • Signature of the personnel on duty.
    • Detailed remarks regarding any external factors (e.g., weather changes or door malfunctions).

5. Handling Deviations

In the event of an abnormality in the environment control readings:

  1. Immediate Notification: Alert the warehouse manager.
  2. Corrective Action: Implement rectification steps immediately (e.g., adjusting HVAC settings or checking insulation).
  3. Reporting: Document the deviation and the subsequent fix to prevent future occurrences

TEMPERTURE & HUMIDITY RECORD SHEET

Area Warehouse / Store

Date

Time

Required Temperature

Actual Temp. Recorded

Required Humidity

Actual Humidity Record

Sign of Inspector

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH

 

 

 

 

30⁰C

 

65RH