Ambient temperature for pharma storage and testing is between +15ºC and +25ºC; this is also considered room temperature for pharmaceuticals.
Pharmaceutical Products are subject to rigorous testing to ensure stability and validity once stored. Stability Chambers are used to form accurate temperature readings at which goods should be kept. Storage temperature is a critical consideration for MHRA (Medicines and Healthcare products Regulatory Agency) approval. The MHRA insists upon thorough testing and reporting, taking into consideration temperature, humidity and various other conditions.
The MHRA
The Medicines and Healthcare products Regulatory Agency is an executive agency of the Department of Health in the United Kingdom. The MHRA is responsible for ensuring that medicines and medical devices work and are acceptably safe.
All Pharmaceutical manufacturers must comply with good manufacturing practice (GMP) and good distribution practice (GDP).
Good Manufacturing Practice (GMP)
The GMP is the minimum standard that a medicines manufacturer must meet in their production processes.
Products must:
- be of consistently high quality
- be appropriate to their intended use
- meet the requirements of the marketing authorisation (MA) or product specification
Good Distribution Practice (GDP)
GDP requires that medicines are obtained from the licensed supply chain and are consistently stored, transported and handled under suitable conditions, as required by the MA or product specification.
Ranges of Storage Temperature
Room Temperature
Most testing and pharmaceutical activities are performed at room temperature. 15-25ºC is considered room temperature for pharmaceuticals. Controlled Samples, Excipients and APIs in pharmaceutical warehouses are all stored at room temperature.
Cool Storage Conditions
8-15ºC is considered a cool temperature range for pharmaceuticals. Some pharma and drug substances that will degrade at room temperature are stored at this temperature to ensure stability and validity.
Cold Storage Conditions
2-8ºC is the recommended Cold Storage environment for pharmaceutical products and substances. Most highly degradable drugs, vitamins and chemicals are stored at this temperature. Between 2-8ºC the rate of microbial growth is slowed and the pace of chemical reactions will also decrease.
In microbiology, storing laboratory reference cultures with the cold storage temperature range will stem their vegetative growth, helping to maintain the substance for more extended periods.
Fridge Storage Conditions
Fridge Storage Conditions range from -4ºC to 2ºC.
CRS Stability & Testing Chambers
CRS offers a range of ambient storage units suitable for pharmaceutical testing and storage. Our cold stores meet all required British Standards and EU regulations. Boasting precise temperature regulation and remote temperature monitoring our controlled ambient units are an essential tool for hospitals and pharmaceutical companies everywhere.
At CRS Pharma Solutions, we can work directly with our client to tailor a solution precisely to your exacting needs. Should you require further components for stability testing, our units can be modified to accommodate almost any request. Our cold stores provide the perfect basis for testing chambers, humidity test chambers, temperature chambers and environmental chambers.
Call today to speak with one of our cold storage experts. Our team have a wealth of experience and will be able to advise on the correct type of cold store and additional products to suit your requirements.
