GDP-compliant nature packaging for Pharma and Life Science Industry – natural, reliable, cooled28.09.2022 | by Miriam Graf
No matter if medications, biologic substances or test kits – pharma and life science products are temperature sensitive and must undergo strict GDP regulations. Thea Hintermeier, biotechnologist and Landpack Head of Operations & Sales, explains how highly sensitive medical products can be cooled correctly and be shipped safely – and that in a sustainable way!
What are the challenges in shipping temperature sensitive pharma and life science products?
Pharma and life science products save lives. To guarantee their quality they must comply to EU guidelines for Good Distribution Practices (GDP). It secures the highest quality standards of pharmaceutical products in a supply chain. Because of that the correct temperature range must be met during all times of the chain. At this point in time many pharma and life science products are sent in Styrofoam packages and even though they are sometimes reused they still have a big negative impact on the environment as they are produced from crude oil, a resource with a finite supply.
How can the Landbox be used in areas of pharma and life science industries?
The Landbox developed by us is the first eco-friendly insulation packaging with the same performance as Styrofoam – while being based on the renewable resources straw and hemp. But not only that: Our Landbox is also well-known for its moisture-regulating and shock absorbing capabilities. It is suitable for the shipment of temperature sensitive medications as well as life science products like e.g. reagents, enzymes or assay-kits. These can be shipped safely and GDP-compliant in combination with cooling- or PCM packs. After usage they can be disposed of in the organic or residual waste bin – with this method a lot of plastic waste is prevented.
In which temperature ranges can the Landbox be used for?
The compliance of the cooling chain and product specific temperature ranges for pharmaceutical products is strictly specified in EU-GDP-guidelines. Life science products, especially enzymes, are very temperature sensitive and must arrive in the laboratories at the perfect temperature. Our insulation packages have already been pre-certified for the ranges frozen (< -20 °C), cool (2-8 °C) and ambient (15-25 °C). We develop and validate individual packing compositions for our customers while satisfying international standards of cooling logistics (e.g. AFNOR oder ISTA). For that we trust in our knowledge and experience from over hundred cooling tests.
How does the validation process work for customer specific requests that differ from the standard?
In case the requests from our customers vary from standards, we will provide you with individual and personalized packaging solutions, which are later validated with GDP standards in our test lab. We gladly test with our customers‘ own products.
Our cooling tests are carried out in a certified climate chamber, that can simulate complex cooling chains between -30 °C to 200 °C. You will receive a test protocol as well as a certificate with packaging suggestions.
How can the purity of the Landbox be ensured?
Our Landboxes follow highest hygiene and quality standards. For production we only use pure and cleaned straw of foodstuff quality. During harvest and storage highest quality criteria are in place. While processing, the straw is dedusted, cleaned and disinfected. Compliance with international standards for the production of packaging is ensured by high hygienic regulations (DIN EN 15593, GMP-Verordnung (EG) Nr. 2023/2006, (EG) Nr. 1935/2004). Also, continuous microbiological tests by our own and other independent laboratories make sure the microbiological thresholds are met.
What has to be taken into consideration when packing the Landbox?
The cooling performance is strongly dependent on the outside temperatures, the amount of gel packs, temperature of the goods, volume inside the box and the composition of goods inside the Landbox. Especially meeting the “cool” range (2-8 °C) the optimal packing composition varies from season to season. Our customers receive seasonally different packing recommendations that were validated in our climate chambers.
Generally, you should make sure to press the panels as tightly together as possible to enable their best insulation performance and keep your products at a constant temperature. Furthermore, the cooled space should be as small as possible for the best results. This can be achieved, because the top panel is loose and can be pushed down to lower the free space. Make sure the cooling elements are completely frozen – in normal freezers this may take up to three days.
How eco-friendly is the Landbox?
The Landbox is sustainable throughout all life cycle stages from the natural resources to the waste management. Straw is a side product during crop harvest and rarely used until now. Landpack straw is produced in the close vicinity around the production site. Because of that we can guarantee 100% transparency and safety throughout the supply chain and minimize our ecological footstep with transportation distances below 10km. Our production procedure is focused on maximizing energy efficiency and needs only 1/50 of primary energy in comparison to Styrofoam. Also, the water usage is small with only 1,5% in comparison to paper. And the best thing: because our insulation packages do not contain any additional supplements, they can be thrown into the organic waste bin. They can then be transformed to biogas and used as a green energy and heat source.
Can the Landbox be sent internationally?
Yes! The Landbox can be sent internationally. Many of our life sciences customers use solely the Landbox for international refrigerated shipping and ship reagents, enzymes and assay-kits to over 170 countries – within a delivery time of 72 hours. Our customer QIAGEN for example ships its products in 177 countries with the Landbox straw. For more information go here.
Especially in many countries of the South the waste is placed in landfill or burned. The Landbox can be consciously used for landfill as it decomposes itself. No harmful gases are released during incineration.