Pharmaceutical storage standards

The pharmaceutical industry is among the biggest in America, generating hundreds of millions of dollars in sales annually. Given the special storage, security and preservation needs that many pharmaceutical products require, businesses in this space must ensure their safe and dependable storage. A study by the Mayo Clinic found that approximately 70% of Americans take at least one prescription medication. Ensuring these treatments maintain their efficacy requires careful preservation from the manufacturer to the pharmacy.

Significant efforts to keep medications in their best condition are required across the supply chain. Accordingly, approximately seven out of ten top pharmaceutical products require temperature-controlled transportation and pharmaceutical storage facilities. For example, just two degrees Celsius of temperature variation could completely ruin certain pharmaceutical products. SciSafe provides a broad range of storage conditions for pharmaceuticals, including the following pharmaceutical sample types:

  • Clinical Trials
  • Bulk API
  • ICH Stability Storage (All standard and any custom condition)
  • Vaccine Storage
  • Shipping Lane Studies
  • Stress Testing
  • Packaging/Pallet Testing
  • Medical Devices
  • Clinical Retains

Safety Regulations Compliance and Best Practices: Pharmaceutical storage conditions are also subject to federal regulations. To ensure compliance, products must be carefully safeguarded in a locked facility. Items should be stored on security shelving with compartmentalized storage space and locking doors.

Environmental and Temperature Conditions: Many pharmaceutical products are vulnerable to temperature fluctuations. Temperature and pharmaceutical storage requirements vary by product; be sure you know that the facility environment your products are stored and transported in will keep them safe, fresh and effective. This also includes preventing any cross-contamination between products by keeping different products isolated from each other. Be sure to clearly label all items and maintain storage areas with clear visibility and no obstructions.

Contingency Planning. Researching new and changing pharmaceutical products requires an extensive study and testing process. Stability studies are used to determine how and the extent to which active pharmaceutical ingredients react to exposure to various influences, including temperature, humidity and light.

Damage to stored samples could cause serious financial loss and slow the pace of development. Accidents can have severe effects. For example, pharmaceutical storage facility damage caused by fire, extreme weather, electrical problems, and power outages may significantly affect stability storage, and lead to damage to samples in storage. Contingency and disaster recovery plans, such as contingency storage at a second facility, can mitigate these risks and provide peace of mind.

Engaging an experienced stability storage provider is critical to your products’ successful development. SciSafe provide its clients with the highest level of service and expertise in the industry.

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