-65℃ Ultra-Low Temperature Pharmaceutical Cold Storage
24-hour all-weather -60℃ to -55℃ operation across 4 rooms for a well-known enterprise.
- 400 m² (4 rooms)
- -60℃ to -65℃
- 180 days
- 2022
Background And Requirement
A leading Chinese pharmaceutical research institute needed ultra-low temperature storage (down to -100℃) for vaccine R&D, biologics stability testing, and GLP-1 drug sample storage. This is significantly colder than standard pharma cold chain (2-8℃) and requires cascade refrigeration — no single-stage compressor can achieve such low temperatures.
Howcool designed a two-stage cascade refrigeration system using R404A in the high-stage (condensing at +35℃) and R508B / R23 in the low-stage (evaporating at -110℃). The system delivers stable -100℃ at the evaporator, with ±0.5℃ control accuracy for GLP-compliant stability testing.
The facility is classified as GMP pharmaceutical-grade, with 4Q validation (Design, Installation, Operational, Performance qualification), full audit-trail data logging, 21 CFR Part 11 compliant software, and redundant refrigeration (N+1) to guarantee zero downtime. Temperature excursion alarms are transmitted to 5 mobile phones + email within 30 seconds.
Project Facts
| Location | China |
|---|---|
| Capacity | 400 m² (4 rooms) |
| Temperature | -60℃ to -65℃ |
| Programme | 180 days |
| Completed | 2022 |
| Sector | Pharmaceutical |
Custom ultra-low temperature cold storage with -65℃ design storage temperature. 400m² divided into 4 rooms. 24-hour all-weather temperature of -60 to -55℃ with dual refrigeration redundancy.
How The Project Was Delivered
- 01
User Requirements & DQ
Design Qualification with client's quality team. URS covers operating range, control accuracy, data logging, alarm response, redundancy. Approved before design freeze.
- 02
Cascade System Design
R404A high-stage + R508B low-stage. Cascade heat exchanger dimensioned for full-load plus 20% margin. N+1 redundancy on both stages.
- 03
IQ + OQ + PQ
Installation Qualification with pipe-pressure tests. Operational Qualification with empty-chamber temperature mapping (49-point grid). Performance Qualification with loaded chamber, 14-day continuous run.
- 04
Training & Handover
Staff trained on monitoring, alarm response, PM schedule. Full IQ/OQ/PQ documentation pack handed over for regulatory audit.
What Was Supplied
- Cascade refrigeration system — R404A/R508B two-stage
- N+1 redundant compressor packs (both stages)
- Specially-designed cascade heat exchanger
- Ultra-low temp insulation chamber (300mm PU + PIR)
- Sealed glove-ports for sample retrieval without full opening
- Independent 49-point temperature mapping system
- 21 CFR Part 11 compliant data logger
- Mobile / email alarm system (5 recipients, 30-sec SLA)
- Emergency backup: CO₂ injection system (reaches -78℃ passive)
- UPS + generator backup power
- Full IQ/OQ/PQ documentation package
Results At Handover
Achieved Temp
Cascade system reaches -100℃ with ±0.5℃ control accuracy.
Validated
Full DQ/IQ/OQ/PQ documentation. Passed regulatory audit first time.
Redundancy
Both cascade stages have N+1 redundant compressors — zero downtime design.
Photographs From Site
Questions About This Project
How large is the -65℃ Ultra-Low Temperature Pharmaceutical Cold Storage project?
400 m² (4 rooms), located in China.
What temperature does the facility operate at?
-60℃ to -65℃.
How long did the project take?
180 days, completed 2022.
What equipment was supplied?
Key items included cascade refrigeration system — r404a/r508b two-stage; n+1 redundant compressor packs (both stages); specially-designed cascade heat exchanger. Full equipment lists are issued with the design pack.
Can Howcool deliver a similar facility for us?
Yes. Send your storage volume or tonnage, target temperature, product type and site location, and our engineers will return a preliminary design and budget estimate within 48 hours.
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Planning Something Similar
Send your volume, temperature, product type and location. Our engineers respond within 24 hours with a preliminary design.