BS3 provide specialist cold chain management for pharmaceutical goods. We are fully licensed and meet all Government regulations to store and distribute pharmaceutical goods.

Cold chain management

Some pharmaceutical products are required to stay between the temperature conditions of +2.0°C to +8.0°C. If the product is exposed to temperatures outside this band, the product can lose its effectiveness and potency. These requirements are set by the manufacturer based on their stability data and other testing practices.

Cold chain management starts from the moment the product is manufactured, through distribution centers, and finishes when the patient is administered the product.

Cold chain management requirements

Typically, cold chain products are required to stay between +2.0°C to +8.0°C, some products will have stability data which allows it to be exposed to higher or lower temperatures for a certain period of time (for example, up to +12.0°C for no more than 15minutes.) This criterion is different for every product, and it is best to check with the manufacturer for more information.

The Australian Department of Health have released a national vaccine storage guideline ‘Strive for 5’. This details the recommended cold chain management of vaccines.

Ultra Low Temperature (ULT) & Controlled Room Temperature (CRT) storage solutions

BS3 is proud to be working closely with Liebherr to provide Ultra Low Temperature (ULT) storage for pharmaceutical materials requiring storage at -80°C.

This demanding temperature zone is critical for new and emerging products and BS3 provides the capabilities essential to meet the specialty needs required in this area.

At BS3, we also offer fully validated and mapped 15-25°C Controlled Room Temperature (CRT) storage to service existing and emerging clients.  This key temperature zone is an essential requirement for the pharmaceutical industry.

BS3 provides boutique storage solutions to meet the needs of our customers, whether it be as small as a single unit, clinical trial products, or other pharmaceuticals with stability requirements in this zone.

As with all our temperature zone systems at 2-8°C, 15-25°C, -20°C and -80°C, the systems are fully mapped, validated, and backed up with uninterrupted power supply solutions and back-to-base monitoring of temperatures.

These systems are critical to ensure compliance and meticulous records are kept to ensure the continuity of our client’s temperature-controlled storage is maintained and proven.

Cold chain management breaches

A cold chain management breach occurs when the vaccine or product is exposed to temperatures outside the recommended storage temperature of +2.0°C to +8.0°C. A breach can occur during any part of the journey.

BS3 are experienced cold chain management specialists with the technologies in place to capture any anomalies and ensure the safety of our client’s products.

Cold chain packaging

BS3 uses a range of validated cold chain packaging or specific solutions as nominated by our clients.

A temperature data logger is commonly used in cold chain packaging, monitoring the temperature throughout the journey to the customer.  When the customer receives the product, they check the logger to ensure the optimum temperature has been maintained.  If the temperature is breached during transport, the product is quarantined, and the appropriate authorities are notified (supplier).

Our staff at BS3 are highly trained in Cold Chain Management from the moment a delivery is received, put away and then dispatched to a customer.

Cold chain storage

Vaccines and other products required to maintain +2.0°C to +8.0°C should be stored in a purpose-built refrigerator/cool room. Domestic refrigerators are not suitable and should never be used.

BS3 has a state-of-the-art purpose-built cool room that is continuously temperature monitored to ensure there are no temperature breaches, including a backup generator to ensure continuity. BS3’s facilities are temperature mapped periodically to ensure there are no hot or cold spots.

All staff at BS3 are thoroughly trained in the handling of cold chain products and follow strict operating procedures (SOPs) to ensure the continuity of care of the products.

Cold chain logistics

Cold chain logistics involves the transportation of vaccines or products from point A to point B. When validated cold chain packaging is used, standard couriers can be contracted (Toll, DHL).

The outer shipper should be identified as urgent and contains temperature-sensitive product, however, it should not be treated any differently (must not be put in a freezer or fridge unless the cold chain packaging is validated to this).

Deliveries of the cold chain should be made within 48 hours to mitigate and cold chain breaches. If undelivered within 48 hours, procedures should be in place to investigate and ensure it is received as quickly as possible.

TIP: Send cold chain shipments at the start of the week so they don’t get held up over the weekend.

FAQs

The correct storage and transportation of vaccines and pharmaceutical product whilst maintaining the recommended temperature range of +2.0°C to +8.0°C.

This is done by using a combination of purpose-built cool rooms, validated cold chain packaging systems, and adequate training throughout the supply chain.

The cold chain product must be quarantined immediately, and the appropriate authority/supplier notified. They may request evidence documents to see how long it was exposed to temperatures outside the recommended temperature.

Cold chain packaging consists of packaging that is rigorously tested in laboratories to ensure product inside is maintained at the required temperature when subjected to outside influences such as summer or winter temperature conditions. It often consists of conditioned gel bricks and a polyurethane container.

BS3 are experts in cold chain management, contact us so we can discuss how we can help you.

FAQs

Yes, we welcome potential customer to visit our facility; however, there are various health, safety, and security guidelines, so you will need to book your visit in advance.

The Therapeutic Goods Administration (TGA) sets high standards for products to be bought, sold and distributed throughout Australia, including pharmaceuticals, medicines and other specialists’ goods. Please contact the TGA for further information.

Most of our clients sign a 12-month contract to use our storage facilities; however, we understand each client needs are unique and can discuss this with you. Our goal is to build trustworthy and long-term professional relationships with our clients.

After we understand your needs and follow a discussion with our team, we will provide a custom quote.

We have no minimum storage requirements and can store products large or small.

No. We will store products if we can and manage any requirements relating to the storage of that unique product.

Yes. We create unique storage spaces to suit client’s specific requirements. Our licensing requirements ensure we are adequality enable to manage products and eliminate risks of contamination.

The World Health Organisation (WHO) confirms that good manufacturing processes are crucial to ensure products are manufactured and controlled to high standards to retain their quality.

We require a flat fee for storage rental space, and after a discussion with one of our team members, we will also supply you with a quote for your tailor-made storage solution.

BS3 security features include a secure gated facility, restricted access for visitors and staff, high-end 24/7 security cameras around the facility. We also provide backup generators to ensure there are no power issues, door scanners and various security methods and procedures for entering and leaving the facility.

Once your products are picked and packed, we work with our network of accredited couriers to ensure delivery to your consignee.

GDP are certified standards that business can achieve through certification and help maintain the quality and safety of products during distribution.

How can we help you? Contact BS3 today.