BS3 provide critical pharmaceutical storage

BS3 offer fully validated and monitored pharmaceutical storage facilities for S2, 3, 4, 8, and 9 materials and medical devices.  Pharmaceuticals and other life science products are delicate products often being affected by light, humidity, vibration, and temperature.

Regulatory requirements

In Australia the Therapeutic Goods Administration (TGA) and State Health Departments collectively manage storage requirements specifically for pharmaceutical goods. They have linked the drug suppliers’ ability to sell and operate in Australia, to their ability to safely store the pharmaceutical products. An inability to competently store the pharmaceutical goods may affect the company’s ability to operate in Australia.

Therapeutic Goods Administration
BS3 offer different types of pharmaceutical storage
Cold chain storage

Cold chain refers to products that are required to maintain +2.0°C to +8.0°C. Often these pharmaceuticals cannot be frozen. Other drugs are sensitive to warmer temperatures. And as many refrigerators operate at +2.0°C to +8.0°C this has become the default upper temperature.

Controlled room temperature

Controlled room temperature or ‘CRT’ products typically refer to products that require to be maintained between +15.0°C to +25.0°C. It is a range that was developed to describe medicines that could be stored at “normal” room temperature, but still had temperature requirements (can’t be too cold or hot).

Uncontrolled temperature storage

BS3 offers uncontrolled temperature storage associated with therapeutic medicinal products.  It is a temperature bracket where packaging and containers can be stored without the need for air conditioning.

Frozen storage

Frozen storage can mean anything under 0°C. In this temperature bracket, different products can have vastly different requirements. Some products can be kept frozen at the “typical” -20.0°C; others must be kept at minus -80°C (dry ice) or even in cryogenic conditions -200°C (liquid nitrogen).

Other requirements for pharmaceutical storage?

Having the correct equipment and facilities is the first step to correct pharmaceutical storage, but there are a list of other requirements that a company must comply with such as the TGA, Good Wholesaling Practices (GWP), Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP) as well as state regulatory requirements. Below are a few requirements for facilities.

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

Pharmaceutical products are often expensive and/or goods with high illicit value (GHIV), which in turn makes them require enhanced security.  The scheduling of drugs assists in determining the secure storage requirements for products.

BS3 has installed vaults and security systems, compliant with regulations to ensure the highest security for our client’s products.  Accessibility is restricted to vetted authorized BS3 staff members.

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.

Modern warehouse management systems facilitate this by checking bar codes at each transaction and, storing the information for easy retrieval. 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.

BS3’s pharmaceutical storage solutions

BS3 specialises in pharmaceutical storage and distribution. We have a team that comes from all areas of the industry which strengthens our ability to understand and service our clients.

Our purpose-built cool room, CRT area, and walk-in vault offer solutions for all types of clients and cold chain requirements.

The design of our facility mitigates many of the common risks, ensuring we know our client’s products are stored safely and securely.

  • A backup generator that will automatically kick in if there is an interruption to the power supply.
  • We have alternating refrigeration & air-conditioning units that ensure if one unit breaks down, the other will automatically turn on.
  • Our facilities are remotely monitored, and our management staff is notified if there are any faults with the facility.
  • We have a temperature monitoring system that will notify management of any pre-excursion temperature limits as well as actual temperature excursions.

BS3’s greatest competitive advantage is its Warehouse Management Portal. The portal gives clients 24/7 access to their stock levels, notifies BS3 of incoming stock, issues sales orders to be picked and dispatched and tracks dispatched orders. BS3’s business portal tracks all stock movements and can be accessed anywhere, anytime.

How can we help you? Contact BS3 today.