Analysis Leads to Product Integrity Assurance


product integrity


Client Basics

Client: Canadian Biopharmaceutical Manufacturer
Destination: India From Canada
Project Scope: Complete Packaging Qualification and Shipping Tests Within 15 Weeks
Unique Factors: Product Launch

Background

A biopharmaceutical manufacturer contacted LifeConEx to facilitate the launch of a new chemotherapy product. The medicine was scheduled to be shipped to India for packaging into finished doses. The manufacturer had limited logistics and quality resources and was positioned in a geographically remote location in Canada. Reverse logistics processes would also need to be implemented because a portion of the product would need to be returned from India back to the manufacturer in Canada. Past shipments from Charlottetown (YYG) on Prince Edward Island to Mumbai (BOM) and BOM to YYG had been performed with mixed results.

Based on the initial shipments’ lack of cold chain control, the Canadian manufacturer saw an urgent need to further qualify the trade lane. With limited internal resources, the manufacturer sought a partner it could trust to perform packaging qualification and shipping tests within a 12-to-15-week time frame.

Approach

LifeConEx conducted a three-step analysis.

Step 1: Cold Chain Infrastructure Analysis

Understanding the infrastructure of a cold chain is key when designing the transportation routing. The logistics process must ensure packaging can be placed inside a proper temperature-controlled storage environment when needed. The average high temperature in Mumbai is 40°C with a relative humidity of 95 percent, and so this was an immediate factor for consideration.

The recommended port of entry into and out of India is Hyderabad (HYD) because it possesses the most sophisticated cold chain infrastructure in the country. The following are further aspects LifeConEx considered for the client’s unique requirements:

  • The major airlines operating in and out of HYD are all preferred carriers within the LifeConEx network, which means they have demonstrated a commitment to maintaining a high level of pharma storage and handling standards.
  • The primary ground handling agent at HYD understands the importance of tarmac considerations and knows that pharma and perishable shipments are different.
  • Trusted trucking networks with refrigerated capabilities can move pharma products from HYD to various parts of India domestically.
  • Dedicated electrical outlets are available for Unicoolers and Envirotainer e1s. Having access to electrical outlets can sometimes be a problem in ports with limited cold chain infrastructure.
  • Passive shipping systems are currently being handled by HYD, with the majority of the systems possessing validation times ranging from 72 to 120 hours.
  • The logistics routing from Canada to India is estimated at 96 hours with an additional customs clearance time of 96 to 120 hours.

Step 2: Packaging System Analysis

LifeConEx compared the advantages, disadvantages and capabilities of the different types of thermal shipping systems available to the client and cross-referenced this data with the product stability data.

The container selected for thermal testing was the P-002 BioSphere, a polyurethane shipper manufactured by EnviroCooler. These shippers are designed to maintain a 2° to 8°C range for up to 183 hours utilising only frozen gel packs. 

Additional benefits of the selected container as it applied to the client’s chemotherapy medicine:

  • Premolded conduction blocks reduce temperature pockets.
  • The sliding ice tray separates coolant and product and directs thermal convection to designed locations of the cooler.
  • Interlocking walls, lids and bases reduce thermal convection between the external environment and the engineered internal atmosphere.
  • The convection engine employs predesigned cavities to use thermal convection as an engine to evenly move and disperse energy within the container.

Step 3: Packaging System Simulation

The goal was to target simulated product temperatures in measured locations between 2° and 8°C for a minimum of 120 hours, with allowable temperature excursions during the testing period of up to 25°C and down to 1°C.

Products would be preconditioned at 5°C (±3°C) for a minimum of 24 hours prior to test start. The simulated product temperatures were documented immediately prior to pack-out for testing. This was done because the handling of materials during product packing and test chamber loading could result in initial product temperatures falling outside the conditioning range.

A programmable temperature chamber was used to expose the shipper to the expected temperature extremes likely to be encountered during warm and cold weather shipments. Temperature values of the chamber, the interior of the shipper (multiple locations) and the simulated product were all recorded. Water was used to simulate frozen product for the minimum load (4L) and maximum load (70L) testing.

Solution

The end goal of the Canadian manufacturer was to test the packaging system to failure. Altogether, the three-step evaluation LifeConEx performed provided a holistic view of the packaging performance and set the basis for safe and efficient product transit. The client also needed proper documentation to present to various regulatory authorities — documentation, which LifeConEx established, that demonstrated that the client had a process in place to protect its product for 12 to 14 days.

Results

The final ISTA 7E packaging qualification report, combined with LifeConEx SOP integration, was utilised by the client to fulfill all requirements.

  • Upstream logistics and packaging integration created much faster turnaround on the project than what the client could have achieved internally.
  • A regulatory-compliant SOP was integrated and approved in conjunction with packaging selection and qualification.
  • Overall, the client vastly enhanced logistics practices while incurring a comparable cost to doing the work internally, which freed up many of its resources for other projects.