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Regulatory Compliant Monitoring Solutions

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Temperature Monitoring Solutions: A Glossary of Terms

Temperature monitoring solutions are paramount for measuring product data. By monitoring and recording the conditions of temperature-sensitive products, the risk of detrimental fluctuations is significantly reduced. We use industry-standard wireless temperature monitoring systems, which come with an influx of new terminology. Those new to compliance might not be familiar with these, so below is a handy guide.

Read the glossary of terms below for a breakdown of the terms and abbreviations that appear in data reports, validation services documentation and more.

Product terminology

Ambient temperature – The air temperature in environments where computers and other electronic equipment is stored.

API – Active Pharmaceutical Ingredient.

Autoclave monitoring – Monitoring sterilisation to make sure that the autoclave is performing as it should be.

Calibration services – Checking the specified measurement range documented and calibrating it to ensure optimal accuracy. This provides traceability in line with compliance demands.

Carbon dioxide monitoring – This area of environmental monitoring verifies that ventilation and conditioning units are performing correctly.

Cold chain monitoring – Tracking and monitoring the temperature of products during the shipping process.

Compliance services – In this industry compliance is a requirement. Regulatory compliance is the process of taking steps to ensure adherence to regulations.

Cryopreservation – The process of preserving biological material at low or extreme temperatures.

Data loggers – This is an electronic device that records and stores temperature data over time.

Environmental appliance monitoring – Analysing a range of environmental data parameters for equipment validation.

LCD – Liquid-crystal display. Many data loggers are fitted with an LCD display for a back-lit, clear visual of data.

Light monitoring – A part of environmental monitoring, light monitoring is tracked as it is an environmental factor that could alter the temperature in the environment.

Limit alerts – Pre-set automatic alarms on a data logger that alerts the user if the temperature goes out of range.

Pressure monitoring – Reviewing the effect of environmental pressure and impact that could cause temperature fluctuation.

Relative humidity monitoring – Measuring both moisture and air temperature and detecting changes.

Temperature excursion – A deviation from the specified temperature range. Wireless temperature monitoring systems alert the user of this to avoid deterioration.

Temperature indicators – These are used for a simple pass or fail visual verification of temperature during transit.

Temperature mapping – The collection of thermal stability data across various points in warehouses, storage areas and more.

Wireless temperature monitoring – Wireless temperature monitoring systems track temperature data which is accessible via the Cloud, so the temperature can be checked quickly and without disrupting the environment (i.e. opening the fridge door to read the screen).

 

Validation terminology

21 CFR Part 11 Compliance – If a product generates data or records, or if software is used to store the data, companies must ensure the data is uploaded safely and is secure. Compliance is mandatory.

GDP – Good Distribution Practice.

GxP – The abbreviation for “good practice” quality guidelines and regulations. The “x” refers to the different industries, such as food or pharmaceuticals.

IQ – Installation Qualification. The practice of checking and verifying equipment by testing it.

ISO9001 – The internationally set standard that specifies requirements that must be met. Companies must supply products and services that meet these regulatory requirements in order to achieve a “ISO9001 Certified” status.

OQ – Operational Qualification. The verification process of ensuring that equipment can achieve the requirements for use.

PQ – Performance Qualification. A test to check the performance of equipment whilst it’s being used for purpose.

Real-time validation – Data that is recorded up-to-the-second on data loggers and uploaded instantly via wireless radio modules.

Thermal validation monitoring – The process of checking that equipment and facilities will meet and maintain the required temperature requirements.

URS – User Requirement Specification.

Validation services – The process of rigorous testing that determines that the temperature monitoring systems produce results that meet the specified criteria. If it passes, certification is provided.

 

Regulating bodies/models

BAPW – British Association of Pharmaceutical Wholesalers.

CFR – Code of Federal Regulations.

CPC – Centers for Disease Control & Prevention.

FDA – Food and Drug Administration.

FDS – Functional Design Specification.

IATA – International Air Transport Association

ICH – International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use.

IMB – Irish Medicines Board.

ISBER – International Society for Biological and Environmental Repositories.

GAMP – Good Automated Manufacturing Practice.

HACCP – Hazard Analysis and Critical Control Points.

HPRA – Health Products Regulatory Authority.

MHRA – Medicines and Healthcare Products Regulatory Agency.

PDA – Parenteral Drug Association.

WHO – World Health Organisation.

Wessex Power can help you to meet regulatory requirements, as well as ensuring you are 21 CFR Part 11 compliant. To find out more about how we can provide wireless temperature monitoring system for your business, contact our team today on 01929 459459 or use our online form. We have nearly 40 years of experience and provide lifetime aftercare and support.

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