Hallie Forcinio
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Pharmaceutical manufacturers with temperature-sensitive products enjoy an ever-increasing variety of protective packaging,
environmental monitoring, and shipment tracking options.
Protective packaging
Insulated shippers with vacuum-insulated panels and refrigerants based on phase-change materials have captured market share
from traditional expanded polystyrene (EPS) and polyurethane structures and gel packs or dry ice. High-performance shippers
feature controlled compression lids, vacuum-insulated panels, and +5 °C phase-change material that provides precise and consistent
melt-freeze transition for temperature control. The shippers weigh approximately 50% less than traditional insulated shippers
and cut distribution costs. The design streamlines the preconditioning process and maintains payloads at 2–8 °C for 140 h
in extremely hot or cold ambient conditions, reportedly 30% longer than other options. Thermochromic labels change color to
provide visual verification that shippers are ready to pack (ORCA 2–8 °C shippers, Intelsius).
Many protective packaging designs are single use, but efforts to choose more sustainable options are spurring interest in
reusable designs. One option, available in a single-use or reusable configuration, protects entire pallet loads and maintains
15–30 °C for up to 120 h. The single-use configuration uses a wood pallet and corrugated outer covering, while the reusable
unit uses plastic for the pallet and outer covering (Pallet Transporter CRT, Cryopak).
Reusable designs have become so popular that one supplier has expanded its regional service center to provide more space for
refurbishing its temperature-controlled shippers. Services include quality inspections and maintenance, component replacement,
sanitization, and cleaning via a soon-to-be-certified ultraviolet decontamination process. The company also performs kitting and/or packaging tasks, preconditions
shippers, and provides tracking, custom reporting, and certified testing functions. Its latest reusable design replaces standard
plastic or kraft corrugated outer boxes with a high-density polyethylene outer container that has a projected lifespan of
two or three years. The hardshell outer container holds six vacuum-insulated panels that can be removed and replaced independently
to reduce maintenance costs. Initially available in 10-, 12-, and 16-L sizes, the design also enhances thermal performance
up to 15% versus corrugated outer box constructions (Credo DuraCUBE, Minnesota Thermal Science).
Prequalified units represent another trend. Options include a temperature-controlled system capable of maintaining 2–8 °C
in wintery conditions. Designed to withstand the extreme cold of Canadian shipping lanes, the unit protects its contents in
ambient conditions of -25 °C for more than 72 h (TimeSaverCN72 Extreme Cold PreQualified Shipper, Cryopak).
For less stringent applications, another prequalified design maintains small shipments at 20–24 °C in hot or cold ambient
conditions for up to 24 h. The shipper offers payload space sufficient for up to four, 20-mL vials (TimeSaver 24 CRT Mini
shipper, Cryopak).
A family of prequalified and validated shippers accommodates shipment sizes ranging from a single syringe to an entire pallet.
Most designs combine EPS or low-density polyethylene foam insulation with refrigerants to maintain desired temperatures for
60–120 h (InTemp Pallet Solutions and InTemp Temperature Control Packaging, Inmark). A new in-house laboratory validates the
temperature-controlled packaging.
Another family of prequalified shippers has added a 5-L size to 11- and 36-L options. The reusable design provides protection
for up to 120 h in refrigerated, frozen, and dry-ice temperature ranges depending on the phase-change material used for the
preconditioned thermal-regulating unit (IntelliTherm shippers, Intelligent Thermal Solutions).
