Temperature Controlled Packaging (TCP) solutions

products-servicesCryo Store B.V.
June 10th 2014

 

Overview

Cryo Store’s unique combination of logistical experience and its Temperature Controlled Packaging (TCP) solutions make the organization a perfect partner for life sciences companies that need to use Cold chain logistics.

Cryo Store’s facilities, solutions and in-depth knowledge and networks allow samples and products to be protected at each stage of the temperature-controlled logistics pipeline, ensuring they arrive at destination in perfect condition.

Background

Cold chain logistics describes the complete process of shipping and storing temperature sensitive products through a complete supply chain that extends from manufacturer to end-user. This is achieved using thermal and refrigerated packaging methods combined with logistical planning to protect the integrity of temperature at each stage.

Definitions

The cold chain is thus more than a process of tasks that must be performed to prepare, store, transport and monitor temperature sensitive products. It is also a science that requires understanding of the chemical and biological factors that determine perish-ability.

At the same time, cold chain is also a technology that uses combinations of specialized equipment and physical means to ensure appropriate temperature conditions along the supply chain.

Maintaining temperature integrity requires higher degrees of control in every process involved. This means cold chain logistics demand higher levels of process and technological integration.

History

The first cold chains arose in the late 19th century with the refrigerated shipping movement of meat and other food from rural producers to urban markets, driving new trades between the Americas, Australasia and Europe.

 

The temperature controlled movement of pharmaceuticals and medical supplies began in the 1950s, with the emergence of third party specialists that instituted new methods for global shipment of temperature-sensitive ingredients in compliance with U.S Food & Drug Administration restrictions and other emerging standards. The costs of compliance spurred many pharma companies to rely on specialty couriers rather than completely overhaul their supply chain facilities.

Since the 1990s, cold chain has increased in importance for the pharmaceutical, biotech and life sciences industries with testing, production and movement of drugs increasingly relying on controlled, rapid and uncompromised temperature controlled shipments. Many of the pharmaceutical products that move along the cold chain are in the experimental or developmental phase and therefore critical to the success of clinical research and development. Altogether, the Healthcare Distribution Management Association estimates some ten per cent of drugs are now temperature sensitive. If these shipments should experience any unanticipated exposure to temperature excursions, they can become ineffective or even harmful.

The complexity of current requirements for shipping pharmaceutical, biotech and medicinal products has given birth to highly focused specialist companies like Cryo Store that have developed niche logistical expertise concerning the packaging, storage and shipping of temperature sensitive products.

Requirements

The potential to understand local rules, customs and environmental conditions as well as an estimation of the length and time of a distribution route make them an important factor in global trade. As a result, the logistics industry is experiencing a growing level of specialization and segmentation of cold chain shipping in several potential niche markets within global commodity chains. Whole new segments of the distribution industry have been very active in taking advantage of the dual development of the spatial extension of supply chains supported by globalization and the significant variety of goods in circulation.

Maintaining Controlled Environments

Different products require maintaining specific temperature levels to ensure their integrity throughout the logistics chain. For the pharmaceutical industry, the temperature range of 2 to 8°C is often specified for cold chain shipping. However, specific temperature (and time at temperature) tolerances vary widely with specific products and can go down to -79°C.

Unique to biological shipments, the cold chain may also require additionally maintenance of product specific environment parameters that may include oxygen, carbon dioxide, humidity and other levels, making this a particularly complicated cold chain to operate. This can be particularly challenging in the supply of vaccines to tropical and emerging markets.

Cooling technologies

Being able to ensure that a shipment will remain within a temperature range for an extended period of time depends both on refrigeration method and the type of container used.

Apart from electric refrigeration at its storage facilities, Cryo Store uses three main types of cooling.

  • Dry ice, or solid carbon dioxide, maintains temperatures as low as -80°C over extended periods of time. It is particularly useful for the shipping of pharmaceuticals and biological dangerous and in refrigerated unit load devices for air cargo. Dry ice does not melt but rather sublimates when it comes in contact with air
  • Gel packs contain gel material that can be pre-frozen to act as synthesized ice at zero degrees Celsius while remaining colder for longer, and being totally re-usable. Gel packs can maintain shipping temperatures in the ‘chilled products’ range at between 2 and 8°C. Cryo Store use gel packs that are food grade conforming to FDA regulation 176.170, non-toxic, non hazardous and biodegradable. Specialty gel packs, based on phase-changing materials, can maintain lower temperatures and are also considered benign for air transport.
  • Liquid nitrogen is an especially cold substance at about -196°C that can keep packages deep-frozen over extended periods and is particularly used to transport biological cargo such as tissues and organs. It is considered a hazardous substance for air cargo purposes, which means it must obey particularly stringent documentation and loading restrictions.

Packaging technologies

Cryo Store also offers a wide range of packaging options, including some innovative solutions.

  • Expandable polystyrene (EPS) boxes are a popular choice for shipping temperature controlled goods due to their excellent isolation properties and lightness. Cryo Store maintains a large array of production moulds to provide customers with a wide range of box sizes on demand. EPS is a recyclable material and Cryo Store can arrange collection of used boxes.
  • Biofoam® is a recently developed form of EPS made from Poly Lactic Acid (PLA) that is fully biologically degradable and that has received Cradle to Cradle (C2C) environmental certification. It has similar insulation properties as EPS and can also be offered in various boxes sizes. Biofoam provides a preferred solution for clients who need to maintain high green credentials.
  • Temperature controlled packaging (TCP)is a strong semi-rigid liner that offers better insulation than EPS or Biofoam along with superior physical protection against crushing or impact. No production moulds are needed, meaning that Cry Store is able to design and develop TCP box of any size in immediate response to individual order. Cryo Store’s unique TCP-based box designs also allow different ‘temperature cells’ to be created within a single package. They can also be stored flat and assembled quickly as needed. Where air cargo networks allow overnight shipments, TCP boxes need less insulation, allowing lighter, more compact packages with significant shipping savings.

Validation and Certification

Shipping and storage are extensions of the good manufacturing practice compliance (cGMP) enforced by the various health regulatory bodies upon all drugs and biological products. The cold chain must be validated to ensure that there is no negative impact to the safety, efficacy or quality of the drug substance. The cGMP environment requires that all processes that might impact the safety, efficacy or quality of the drug substance must be validated, including distribution.

Validation

A quality management system (QMS) is needed to manage the cold chain, which needs to measured, analyzed, controlled and validated at each stage. Hazard Analysis and Critical Control Point (HACCP) methodologies provide a useful foundations for a total cold chain QMS.
This leads on to a Validation process that comprises three successive layers of qualifications.

First comes Component Qualification: testing packaging and other physical components for quality, reliability and integrity.
Second, Operational Qualification tests all that processes involved in shipping and storage retain integrity at operational extremes.
Finally, Performance Qualification demonstrates that the system functions reliably within normal limits.

Thermal testing is crucial to validating the cold chain. Certified test labs use environmental chambers to simulate ambient profiles that can be encountered during distribution, with thermocouple probes and temperature data loggers used to measure response of the package to test extremes.

Documentation

Documentation is also critical, with each step of the custody chain required to maintain proper records to show that required protocols have been maintained. Accurate and complete documentation is also needed to eliminate any risk of customs or shipping delays that can compromise the cold chain.

An internal documentation system is essential, along with shared communication standards and protocols, to create a central information hub that can track the whole supply chain, monitoring custody chain, product temperature history, equipment status, etc. These help ensure that a pharmaceutical or vaccine is safe and effective when reaching its intended consumer. Possessing a complete chain of custody for the entire life cycle of a product entails having a documented audit trail as to who had control of the consignment at each stage in the cold chain, right through to final delivery to end-user.

Standards

Pharmaceutical cold chain consignments must also meet specific classification requirements, such as those applying to the packaging of biological specimens or clinical samples under the recent class UN3372 or to comply with ADR, ICAO, or IATA P650 packaging standards.

Cryo Store is experienced in meeting all such standards, with appropriate packaging, cooling media and documented audit processes. For guaranteed product quality, all packaging solutions are extensively tested to international ISTA guidelines and customer specific requirements. Cryo Store is also quality certified to ISO 9001 and ISO 14001 standards.

Services

Cryo Store has over ten years of experience in worldwide cold chain distribution of biological samples, clinical samples, products for scientific research and other temperature sensitive materials. When required, it can provide turnkey solutions; arranging every part of the process from pick up to efficient and timely delivery to the required destination, handling all packing, storage and documentation on the way.

Cryo Store work closely with leading couriers, like TNT, Fedex and UPS, to maintain preferred customer status while maintaining a wide selection of networks to avoid undue dependency on any single provider’s schedule. In this way, Cryo Store can reach almost all locations in Europe within 24-48 hours.

The Cryo Store Cold Chain Logistics service can be extended to other locations in the world, again with all shipping details supplied to clients in daily reports for full tracking and tracing.

Resources

Click on Cryo Store Temperature Controlled Packaging (TCP) solutions for more information.
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Supplier Information
Supplier: Cryo Store B.V
Address: Handelswei 1-A, 8501 XJ Joure, The Netherlands
Tel: +31 (0) 513 415965
Fax: +31 (0) 513 411571
Website: http://www.cryostore.com/