VALIDATION 

ECPL also performs room validation

Pharmaceutical ingredients are placed or stored at various places for example raw material storage area, refrigerator, quarantine area, large cold rooms, packaging room, freezer, warehouse etc. Depending on given storing conditions (temperature and humidity) these are stored in different places.

  • Some are stored in refrigerators eg. Vaccines

  • Some are stored in ambered/dark colored containers to prevent degradation from sunlight

So for maintaining proper storing conditions (temperature, humidity and light) mapping of areas is necessary. Mapping of these areas is important for maintaining stability as temperature and humidity plays crucial role in degradation.

Temperature & RH Measurement

ECPL conduct validation Temperature and Humidity Measurements using portable data loggers as per the requirement of customer.

Need for temperature mapping:

  1. To check whether temperature in whole area is uniform or not and within given specified limits.

  2. To check temperature fluctuations at various locations within the specified area

  3. To record the temperatures at different areas of volume with sensors/probes or data loggers

  4. Preparation of mapping report and taking further actions for improvement in maintaining uniform temperature and air distribution

Mapping area may be any place where pharmaceutical ingredients can be stored or processed for any unit operation. It can be

  • Autoclaves

  • Large cold rooms

  • Incubators

  • Warehouses

  • Stability chambers

Temperature Mapping Operation:

Each mapping is carried out through as per the selected/given protocol. A standard and detailed protocol is used. Portable data logger or wired RTDs with data logger is used for aping. Ideal mapping protocol contains

  • Mapping dates and time

  • Approval page

  • Number of probes to be used

  • Change control history

  • Reviewed and mapped by

  • Acceptable limits and errors

  • Hot and cold spots

  • Methodology used

  • Reporting

Light Intensity Measurement

Lighting level is measured, to verify the installed light levels and uniformity meet the specified requirements. Calibrated lux meter is used to measure the lighting level.