Pharmaceuticals store very sensitive samples and specimens that require very specific conditions to maintain biological and chemical integrity. For this reason, it becomes exceedingly important for these pharmaceutical storage facilities to have the right conditions to sustain both biological and chemical samples. These samples may be sensitive to extreme light, temperature or humidity, and thus require different storage facilities with the optimum conditions.
This post will highlight some of the different storage options for biological and chemical samples and the importance of storing samples correctly and assessing chemical purity regularly.
Different Storage Conditions in Pharmaceutical Storage Facilities
Clean room standards are a must for any pharmaceutical storage facility, but aside from that, other factors come into play when dealing with different types of samples to retain their quality and chemical purity. And with America being the largest chemical manufacturer in the world, biotech companies have to be at their best to keep up with chemical standards. The following are some great examples of common pharmaceutical storage facilities that meet GMP storage conditions:-
1. Room Temperature Conditions
Most pharmaceuticals operate in room temperature of between 20 -25 degrees Celsius. These storage facilities don’t require excessive temperature control since they handle not so sensitive biological and chemical samples. Temperature extremes, however, must still be mitigated, but a normal HVAC system will do just fine for these facilities.
2. Cool Storage Conditions
Just a step below room temperature storage facilities are cool storage facilities that operate at temperatures of between 8 to 15 degrees Celsius. The storage facilities are drug and chemical-specific since some of these substances degrade at room temperature. These temperature ranges are also sufficient for assessing chemical purity of some samples by comparing melting points at these temperatures.
3. Cold Storage Conditions
Cold storage facilities are usually kept at temperatures between 2 to 8 degrees Celsius. The temperature inhibits the proliferation of microbial species. It also decreases the rates of chemical reactions in some specimens. Some chemicals, vitamins, and highly degradable drugs are stored in such conditions. HPLC and GC standards, limit test standards, reference standards, and vitamin standards solutions are some great examples of samples stored in cold storage facilities.
Microbacterials are stored in cold storage facilities as reference solution standards, to maintain them for longer periods by slowing down their growth. For instance, a suspension culture will retain life for approximately one week if stored in cold storage conditions.
4. Fridge Storage Conditions
Storages with temperatures between -4 to 2 degrees Celsius are referred to as fridge storage facilities. This temperature range may hinder microbe growth for some species but may kill others. Pharmaceuticals reserve fridge conditions mainly for volatile chemicals with low boiling points or chemicals that disintegrate at above freezing conditions.
Importance of Storage Conditions for Pharmaceuticals
There are stringent guidelines for pharmaceuticals with a very minimal margin of error regarding temperature storage. These guidelines ensure the stability and integrity of drugs and samples are maintained since even a two-degree Celsius variation could ruin a pharmaceutical product.
The World Health Organization stipulates that pharmaceutical products must be stored in places with good ventilation, away from light and odors, with humidity levels of 60% or lower and temperatures described by the drug and chemicals manufacturer.
Most pharmaceuticals strive to achieve the optimum conditions for drug storage, but it can be difficult and very costly to achieve such conditions. These pharmaceuticals, therefore, outsource their storage to other stability storage facilities for guaranteed compliance and assurance or seek professional help from storage facility experts, who help them in their installation process.
In the GMP storage practices, a little error could be disastrous for samples and pharmaceutical products. For this reason, most pharmaceuticals seek expert assistance to maintain chain custody, carry out the necessary backup procedures, and even assist them in assessing chemical purity. These companies also help them save a lot of money and maintain credibility as pharmaceuticals.
Hopefully, you’ve now grasped the different storage conditions for pharmaceuticals and their importance in assessing chemical purity.