Cryogenic storage in the pharmaceutical industry operates under different standards than in a research laboratory. Storing pharmaceutical active ingredients, biological raw materials, and cellular therapeutics (ATMPs) at –196°C is not a technical detail — it is a critical process step that must be fully qualified, validated, and documented.
A failure in GMP-compliant cryogenic storage does not just cost samples. It costs regulatory compliance and, in the worst case, the manufacturing authorization.
GMP stands for Good Manufacturing Practice — a quality management framework that is mandatory in the pharmaceutical industry and for the manufacture of ATMPs (Advanced Therapy Medicinal Products). For cryogenic systems, GMP compliance means:
Pharmaceutical production strains — bacterial expression systems, mammalian cell lines (CHO, HEK293), or yeasts — must be cryopreserved as Master Cell Banks (MCB) and Working Cell Banks (WCB). These banks are the foundation of all production; their loss would require complete redevelopment.
The BSD+ Series from Consarctic® is designed for these applications: up to 100,000 cryovials, stainless steel, vapor phase storage.
Gene therapies, autologous and allogeneic cell therapies (CAR-T, MSC, HSC transplants) must be frozen, stored, and released under GMP. The BSF+ Series covers cryobag-based storage requirements.
The BIOFREEZE® SMARTLINE is the freezing instrument for these applications: audit trail software, GMP-compliant protocol logging, validatable freezing programs.
Sera, plasma products, virus seed banks, plasmids — biological starting materials for the pharmaceutical industry are subject to GMP requirements of pharmacopeias (Ph.Eur., USP) and EMA guidelines.
IQ documents that the cryogenic system was correctly installed: correct equipment delivered, installed according to manufacturer requirements, infrastructure connections verified (LN₂ supply, alarm connectivity, network for monitoring).
OQ documents that the system operates within specification: temperature ranges, alarm trigger values, sensor calibration, freezing protocol performance. For the BIOFREEZE®, this includes verification of TC-Aktiv function and cooling rate accuracy.
PQ documents that the system reproducibly and consistently delivers intended performance under production conditions — across multiple batches and defined time periods. For cryogenic tanks: stable temperature maintenance under operational load.
Consarctic® performs IQ and OQ as a certified service provider. PQ support is provided in alignment with the customer's internal quality system.
The Consarctic® Monitoring-System meets GMP requirements for environmental monitoring:
Pharmaceutical companies including Roche, Bayer, and GSK use the Consarctic® Monitoring-System as part of their cryogenic GMP infrastructure.
GMP-compliant cryogenic storage means that the storage of pharmaceutical products or starting materials at cryogenic temperatures meets Good Manufacturing Practice requirements: qualified equipment (IQ/OQ/PQ), validated processes, calibrated monitoring, complete documentation, and audit trail.
Biological active substances, cell line banks (MCB, WCB), virus seed banks, plasmids, serum, plasma, and especially ATMP products (cellular therapies, gene therapeutics). All must be frozen and stored under GMP-compliant conditions.
Not always. Minor changes can be assessed through change control with a documented impact assessment, without full re-qualification. Significant changes (system replacement, relocation) require at least partial re-qualification. Consarctic® supports this process.
IQ verifies correct installation. OQ verifies function within specification. PQ verifies reproducible performance under production conditions. All three are components of GMP equipment qualification.
Calibration intervals depend on risk classification and internal SOPs. Typically: annual calibration of temperature sensors, semi-annual verification of alarm functions. Consarctic® offers calibration services as part of the maintenance contract.
Pharmaceutical companies manufacturing biological products have no choice: GMP-compliant cryogenic storage is a regulatory obligation. The question is not whether — but with which system and which partner.
Consarctic GmbH delivers the systems, documentation, and service that GMP pharmaceutical manufacturing demands. With certified technicians, 24/7 emergency coverage, and reference customers including Roche, Bayer, and GSK — contact us to discuss your requirements.