BS3’s storage facilities include:
- Walk-in vaults for storage of Goods with High Illicit Value (GHIV), Schedule 8 and Schedule 9 products.
- A cool room (+2.0°C to +8.0°C)
- A controlled room temperature area (+15.0°C to +25.0°C)
- Deep frozen (ULT) -80°C
- Cryogenics -200°C
- Uncontrolled pallet storage
- Temperature monitoring of all storage areas, which comply with 21CFRpart 11 /EU GMP Annex 11, requirements for Electronic Records and Electronic Signatures.
Controlled room temperature
Controlled room temperature (CRT) products are those that must be kept within a specific temperature range of +15.0°C to +25.0°C. This range was established for medications that, while not needing refrigeration, still have temperature sensitivity and cannot be exposed to extreme heat or cold.
Uncontrolled temperature storage
BS3 offers uncontrolled temperature storage associated with therapeutic medicinal products, where packaging and containers can be stored without the need for air conditioning.
Frozen storage
Frozen storage can range from temperatures below 0°C to as low as -200°C (liquid nitrogen). While some products can be stored at the standard -20°C, others require much colder temperatures, such as -80°C (dry ice). These varying requirements highlight the importance of precise temperature control in frozen storage.
Temperature monitoring
A storage provider must have evidence that the correct temperatures were maintained in the CRT and Cold Room. To achieve this, BS3 has installed a validated temperature monitoring system and backups where the temperatures from various key positions are recorded and available to provide proof that the temperatures have been maintained.
The monitoring system must have alarm notifications if temperatures are exceeded (SMS/email). It is critical that these excursions are addressed immediately as a significant excursion could result in products requiring destruction.
Pharmaceutical storage security
BS3’s facility is protected by perimeter security fencing, CCTV cameras, internal fob access to restricted areas, and an electronic alarm system, all of which exceed all mandated requirements of the Poisons License. The high level of security equips us to offer storage to Schedules 8 & 9.
Pharmaceutical traceability
A fundamental element in working with pharmaceutical products is the ability to perform a mass recall if necessary. Distributors of pharmaceutical products must keep records of what product (strength & dose), batch number & expiry dates were receipted into the warehouse and to whom they were distributed. BS3 has a highly sophisticated warehouse management system to manage this information.
Quality management system
A quality management system (QMS) is quintessential to any pharmaceutical storage facility. Without a robust QMS, regulatory approval would not be granted.
In Australia, the QMS must meet the minimum requirements of the TGA’s Good Warehousing Practice (GWP).
BS3 is accredited with ISO9001:2015 and GWP.
