Monitoring for Regulatory Compliance & Product Safety
Temperature - Humidity - Moisture - Pressure - pH
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Welcome to Rototherm

Issues

Challenges for Pharmaceutical Industry

The importance of Temperature as a critical control parameter for ensuring pharmaceutical quality is recognised by all of the regulatory authorities  e.g  IMB; MHRA;FDA.  (link each of these the relevant guidelines on our site)

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Controlled Temperature Storage (“Ambient”)

Provide documentary evidence that you maintain storage  and transport temperatures for Pharmaceutical/Medicinal product within label requirements  e.g.  “do not store over 25ºC/30 ºC/do not freeze”. In order to achieve this objective the following are necessary as a minimum.

  • Documented temperature mapping studies including empty / full and seasonal
  • Documented proof that temperature monitoring system placement is based on areas of highest risk as shown by temperature mapping studies.
  • Continuous temperature records and timely alerts to temperature excursions including  CAPA
  • Certificates of Calibration

Cold Chain

Provide documentary evidence that you maintain storage  and transport temperatures for Pharmaceutical/Medicinal product within label requirements  e.g.  “ store between 2ºC and 8 ºC”  and  frozen (typically ≤-20 ºC depending on product requirements).   

As a result of our experience in mapping Cold Rooms, Freezers and in Qualifying Shippers we understand the  challenges involved in achieving this goal.

Specific Cold Chain Challenges

  • strict acceptance criteria   visual e.g graphs showing  6deg band and 10deg band
  • target temperatures versus ambient temperatures + pictorial box within a box to represent this
  •  multitude of influencing factors (packaging,transport,season,training, passive (validated insulated shipper) or active cooling (refrigeration), door /package openings, conditioning time, load size, dunnage, control set points, probe type for monitoring,  Static/Mobile Refrigeration temperature range required etc. Note to developers please make this bit appear in cloud)

Nevertheless we still need as a minimum

  • Documented temperature mapping studies including empty / full and seasonal and power off /generator studies
  • documented validation studies of cold chain shippers and transport vehicles/channels
  • Documented proof that temperature monitoring system placement is based on areas of highest risk as shown by temperature mapping studies  (not always  required  for validated shippers).
  • Continuous temperature records and timely alerts to temperature excursions including  CAPA (not always  required  for validated shippers)
  • Certificates of Calibration