	Innovations in temperature-controlled packaging center on sustainability, performance, and cost.

	To improve sustainability, OptumRx, a pharmacy care services provider, has transitioned from rarely recycled foam packaging to recyclable packaging made from renewable cotton-based Kodiakotton from Kodiakooler, which was recently acquired by Airlite Plastics. The Kodiakotton insulating material is biodegradable, compostable, reusable, and recyclable. OptumRx projects the new packaging will save millions of gallons of water, pounds of carbon dioxide, and kilowatt-hours of energy (1). “OptumRX has had great success with our sustainable products,” reports Corbin. “Part of the initiative is ongoing education for their consumers on the benefits of recyclable materials,” he adds. 

	In addition to Kodiakotton liners, Kodiakooler offers the patented Kwikpack system. This is a bundled kit of two Kodiakotton liners with an easy-to-remove, recyclable band. The liner bundle cuts insertion time and results in a packout-ready shipper in less than six seconds (2). 

	Fiber-based options, which can be recycled in the corrugated or waste-paper streams, also are popular. To address this market, Thermo Fisher Scientific has developed the Invitrogen Paper Cooler. The 100% paper alternative to EPS foam coolers meets thermal requirements for overnight shipments (3). Another paper-based product, ClimaCell insulation from TemperPack, is designed to replace EPS insulation and reduce packaging waste. In addition to being recyclable in the corrugated stream, the ClimaCell material protects temperature-sensitive shipments for up to 80 hours. The material also is moisture-resistant and can be customized with printed graphics/messages (4). 

	Another player in the insulation market, va-Q-tec, has opened a US headquarters and production facility in Langhorne, PA, to manufacture its small boxes and containers. The location also serves as a rental and repair station. The company, which is headquartered in Germany, specializes in vacuum insulation panels and phase-change materials that offer five-day temperature protection without the need for external energy sources. A rental service business offers a fleet of cold-chain containers and boxes (5).

	Reuse is possible with the AcuTemp Plus Series of shippers from CSafe Global through its Repaq program. Proprietary, high-performance ThermoCor vacuum-insulated panels control payload temperatures. Simple to deploy, the shippers are available in multiple sizes and temperature profiles with integrated track-and-trace options (6). 

	Although reusable packaging has gained ground, one-way shippers remain a viable choice and continue to evolve. AeroSafe Global, a supplier of reusable shippers, has added a disposable option to its portfolio. The A20 insulated shipper is designed to serve shipments needing protection for 24 to 48 hours. It is fully prequaliï¬ed to ISTA 7D summer and winter proï¬les. Minimal components simplify packouts (7).

	Gore Sta-Pure flexible freeze containers from Gore PharmBIO Products are designed to protect high-value bulk drug substances from container breakage or leakage during frozen handling. “Traditional single-use bags are constructed from materials that typically become brittle when exposed to temperatures below -40 °C, which can lead to cracks or leaks in the bags,” explains Cintavy. The proprietary high-strength fluoropolymer material used for the Sta-Pure flexible freeze containers is durable after freezing at -86 °C (-123 °F) and offers the convenience and scalability of a single-use system that efficiently uses freezer space. In addition to durability, the container’s chemically inert, biocompatible, high-purity fluoropolymer composite film has a low extractables profile (8).

	Gore Sta-Pure flexible freeze containers come in sizes from 50 mL to 12 L with tubing and connector options to meet different pharmaceutical and bioprocess applications. A hard-shell carrier is available for easier handling. If carbon dioxide or oxygen permeation is a concern, an optional, vacuum-sealable, secondary barrier wrap minimizes ingress (9).

	Introductions from Pelican BioThermal include a new version of its ProEnvision web-based asset management track-and-trace software, which allows integration of its CoolPall Flex bulk shipper into the Internet of Things. The CoolPall Flex shipper serves refrigerated, frozen, and room temperature ranges. A high level of flexibility allows the system to address different time, weight, and payload requirements. 

	For cryogenic products, SAVSU Technologies has expanded its portfolio of dry vapor shippers, which maintain biologic payloads at -196 °C during storage and transport. Positioned between the DV4 and the DV10 shippers, the DV7 unit offers seven days of thermal autonomy and a more compact form factor with a payload capacity similar to the DV10 shipper. With its smaller size, the DV7 shipper is easier to handle and store and less expensive to ship (10). 

	Cryoport Express Advanced Therapy Shippers from Cryoport have been developed to meet demand from biopharma customers and in anticipation of more stringent government regulations. The shippers are dedicated to human use and certified as such. Validated to ISTA 3A and 7E Transportation Standards, a new vapor plug design further doubles the holding time if shippers are mis-orientated during transit. The shippers also provide complete traceability of use history and assurance that each dewar is requalified for each trip for physical suitability, cleanliness, liquid nitrogen capacity, and shipment hold times. Validated cleaning processes reduce the risk of cross-contamination during use, delivery, and distribution (11). 

	Sustainability continues to be a major driving force with suppliers and users of temperature-controlled packaging. As a result, work continues on developing designs that meet performance requirements that will be more renewable, recyclable, reusable, and/or compostable. Kodiakooler, for example, is working on biodegradable EPS foam. “We are constantly looking for ways to reduce the carbon footprint of temperature-controlled packaging materials,” says Corbin. 

	1. OptumRx, “OptumRx Introduces 100% Sustainable Packaging for Medication Home Delivery,” Press Release, Aug. 16, 2018. 

	2. KodiaKooler, “Kwikpack, Assembly Instructions,” Video, https://kodiakooler.com/kwikpack/. 

	3. Thermo Fisher Scientific, “Invitrogen Paper Cooler,” Thermofisher.com/order/catalog. 

	4. TemperPack, “TemperPack Launches            ClimaCell, a Certified Recyclable Packaging Solution for Perishable Shipments,” Press Release, May 10, 2018. 

	5. va-Q-tec, “va-Q-tec Expands in US,” Press Release, Jan. 19, 2018. 

	6. CSafe Global, “CSafe Expands Cold Chain Offerings for the Cell and Gene Therapy Market with Launch of High-Performing Acutemp Plus Series of Temperature-Controlled Packaging,” Press Release, Dec. 13, 2019. 

	7. AeroSafe Global, “AeroSafe Global Introduces Lower-Cost, Single-Use A20 Insulated Shipper Line,” Press Release, Oct. 23, 2018. 

	8. W.L. Gore & Associates, Inc., “Gore to Launch GORE STA-PURE Flexible Freeze Containers at BioProcess International,” Press Release, August 24, 2018. 

	9. W.L. Gore & Associates, Inc., “GORE STA-PURE Flexible Freeze Containers,” Gore.com. 

	10. SAVSU Technologies, “SAVSU Technologies Launches Two New evo Smart Shipper Models to Improve Apheresis Collection Shipments and Cryopreserved Cell and Gene Therapies,” Press Release, Jan. 22, 2019.  

	11. Cryoport, Inc., “Cryoport Introduces Cell & Gene Industry’s First Dedicated Shipper for Advanced Therapies,” Press Release, Sept. 18, 2019.  

	Hallie Forcinio is packaging editor at 

Articles

Feature

Innovations in packaging protect temperature-sensitive drugs.

Sustainable and Functional Packaging Meets Cold-Chain Needs

	The level of automation in the bio/pharma industry varies and continues to evolve. Many are investing in Industry 4.0 concepts such as digitalization and automation to improve manufacturing efficiency, quality, and capacity. According to Amos Dor, general manager of the Applied Materials’ Automation Products Group, one such capability for improving operations is advanced analytics, which takes manufacturing data and provides insights into how the process and equipment are holistically performing.  Analytics-combined with advanced scheduling solutions-can be used to minimize downtime and identify additional capacity within existing manufacturing constraints, says Dor. To further examine current trends in pharmaceutical manufacturing, 

spoke with Dor and with Amy Doucette, manager for the Americas for Applied Materials’ Automation Products Group, Pharma Solutions. 

What are some ways to address the problem of how a lack of manufacturing capacity or quality impacts drug shortages? 

We see that the pharmaceutical industry is investing in digitalization of their manufacturing facilities. They are trying to extract value from the data being collected on the plant floor by using machine learning and advanced analytics to gain insight into how their process and equipment are holistically performing. For example, our advanced analytics and control solution applies analytics to automate business processes end-to-end to increase quality and productivity in pharmaceutical manufacturing.  

	In addition, the ability to integrate directly to the plant floor enables an advanced scheduling digital twin with optimization algorithms and expert rules to manage the plant, ensuring schedules are realistic and optimal for the next schedule horizon.

How are digital twins being used in pharmaceutical manufacturing? 

Pharma is taking a phased approach to implementing digital twins. Some companies are starting in the quality control (QC) lab because QC is integral to ensuring that products are released on time. Others are taking initial snapshots of one manufacturing line and eventually building out to the entire manufacturing facility and its supply chain. 

	Digital twins allow scenario planning, using our scheduling solution, to go through different scenarios for how a company can debottleneck a process. Sometimes the process can be optimized by simply changing the schedule, and other times adding equipment or operators should be evaluated. Using these solutions, the workforce can work smarter to increase productivity and quality by increasing yields, reducing variability, minimizing downtime, and identifying capacity within existing manufacturing constraints.

What are some of the key lessons pharma can learn from other industries-such as semiconductor manufacturing-on modernizing manufacturing?  

As James Moyne from Applied Materials and co-authors wrote in 2017, the semiconductor industry, which operates at higher process capabilities and overall equipment effectiveness than the pharmaceutical industry, can serve as a role model. Semiconductor chip manufacturing has used advanced sensing and diagnostics, advanced process control, and robotics and automation, as well as advanced dispatching and scheduling, to achieve profitable productivity and quality (1).

	Looking at the BioPhorum Operations Group (BPOG) plant maturity model (2), many pharmaceutical manufacturers are moving from digital silos (Level 2) to a connected plant (Level 3). The goal is a predictive plant (Level 4) and eventually progressing to an adaptive plant (Level 5). The semiconductor industry has been on this journey longer. In the pharma industry, we are working to help companies connect the silos. We have an agnostic platform that sits above the automation system and integrates with manufacturing execution systems (MES) and enterprise resource planning (ERP) systems. We are working with internal Applied Materials groups, equipment manufacturers, and sensor companies to enable a modular “plant in a box” that integrates predictive analytics with other layers of automation, such as inspection, MES, and ERP.

	1.    S. Romero-Torres, J. Moyne, and M. Kidambi, 

Development of a Digital Plant Maturity Model to Aid Transformation in Biopharmaceutical Manufacturing

Analyzing process and equipment data provides insights that can improve quality and productivity of pharmaceutical manufacturing.

Equipment and Processing Report-04-22-2020

Sustainable and Functional Packaging Meets Cold-Chain Needs

Analytics Boosts Manufacturing Capabilities