21 CFR Part 11
Per-user authentication, role-based access, electronic signatures with reason codes, full audit trail with non-deletable history.
Pharmaceutical · Sterile Injectables · Biologics
GMP Freeze Dryers for Sterile Injectables and Biologics
21 CFR Part 11 audit trail · SCADA integration · 316L contact parts · IQ/OQ/PQ packages.
Built and verified for regulated production
- ISO 9001 quality system
- CE / PED conformity
- Reference customer: WHO-prequalified vaccine manufacturer in Southeast Asia
- Reference customer: top-20 sterile injectables producer in Asia
Compliance & Validation
Our GMP control platform is designed around regulators’ expectations from the first commit, not retrofitted at FAT.
Data integrity (ALCOA+)
Time-stamped records, system clock synced to a reference, batch/recipe export with hash, controlled review/approval workflow.
Validation documentation
URS, FAT, SAT, IQ, OQ, PQ and DQ packages provided with every pharmaceutical unit. Sample template chapters available on request.
EU GMP Annex 1 (2022)
Compatible cleanroom interface design, CIP/SIP options, isolator-friendly load/unload, contamination control strategy support.
Engineering Specifications
Pick a model by shelf area; ask us for full datasheets.
| Model | Shelf area | Condenser temp | Typical use | |
|---|---|---|---|---|
| Command SJ-50F(T) | 0.5 m² | ≤-85 °C | Sterile / vial lyophilization | View product |
| Command SJ-100F(T) | 1.0 m² | ≤-85 °C | Sterile / vial lyophilization | View product |
| CommandSJ-200F(T)-30L | 2.16 m² | ≤-85 °C | Sterile / vial lyophilization | View product |
| Command SJ-300F(T) | 3.2 m² | ≤-85 °C | Sterile / vial lyophilization | View product |
| Command SJ-500F(T) | 5.4 m² | ≤-85 °C | Sterile / vial lyophilization | View product |
| SJ-Command F10M | — | — | Sterile / vial lyophilization | View product |
Reference deployments
A few of the production environments where SJ Scientific GMP freeze dryers run today. Customer names withheld where required by NDA.
Vaccine bulk lyophilization
A WHO-prequalified vaccine manufacturer in Southeast Asia operates a Command 500F system on an influenza vaccine bulk line.
Monoclonal antibody pilot
A top-20 Asian biotech runs cycle development on a Creator pilot system before scaling to a Command 200F production line.
Peptide sterile API
A specialty peptide CDMO uses a Command 100F(T) for small-batch sterile API lyophilization with full IQ/OQ/PQ documentation.
Service & Support
FAT in our factory
Witness shelf uniformity, vacuum tightness, control system tests, and validation document review before shipment.
SAT and on-site commissioning
Local engineer dispatch in 30+ countries; remote diagnostics standard on every system.
Operator and validation training
Two-tier training: HMI + recipe operations for production teams, plus protocol walkthrough for QA / Validation.
Spare parts & lifecycle
<72h response SLA; 10-year spare parts commitment for pharma systems.
Hong Kong On-the-Ground
For HK-based pharmaceutical and CDMO buyers — local invoicing, founder access, fast service.
Founder-level access for GMP buyers
For pharmaceutical capital purchases, our founder is regularly in Hong Kong and available for in-person validation strategy and contract discussions.
HKD invoicing · HK procurement compatible
HKD quote and invoice options. Documentation aligned with HK Department of Health and Hospital Authority procurement processes.
48-hour engineer dispatch in HK
In-region service across Hong Kong. Critical for GMP production where downtime = batch loss. No cross-border customs delay.
Bilingual validation packages
IQ/OQ/PQ documentation in English and 繁體中文 as standard. Audit-trail exports compatible with HK regulatory inspections.
Frequently asked by procurement and QA
Do you provide GAMP 5 documentation?
Yes. URS, FS, DS, traceability matrix, and risk assessment templates are part of our pharmaceutical documentation package.
What's the typical lead time for a Command 500F system?
14–18 weeks ex-works depending on the validation scope and customization. FAT and shipping add 2–4 weeks.
Can you support EU GMP Annex 1 (2022) requirements?
Yes. We support contamination control strategies, isolator-compatible loading, and qualification approaches aligned with the 2022 revision.
How does your audit trail meet 21 CFR Part 11?
Every action that affects records is logged with user, timestamp, before/after value, and reason code. The trail is read-only and survives system restarts.
Do you support remote diagnostics?
Yes, via VPN or customer-controlled jumpbox. We do not require an outbound internet connection from the GMP network.
What sterilization options are available?
CIP and SIP options are available for the chamber and condenser on Command series. The cleanroom interface and dryers can be specified for VHP-compatible operation.
Pharmaceutical Freeze Dryer Systems
Pharmaceutical freeze dryers are selected for more than cold performance alone. Buyers usually compare process stability, validation readiness, chamber configuration, and the supplier's ability to support scale-up from development to production.
What matters in pharmaceutical freeze drying
- Stable shelf temperature control for repeatable recipes
- Vacuum performance that supports consistent primary and secondary drying
- Chamber and shelf configurations suitable for vial and bulk applications
- Documentation and automation options that fit GMP environments
Typical applications
- Sterile injectable products
- Biotech intermediates
- Peptides and proteins
- Temperature-sensitive pharmaceutical formulations
When this page is most relevant
This page is intended for teams comparing pharmaceutical freeze dryer solutions for new process lines, pilot validation, or commercial manufacturing upgrades.
Next step
Review the GMP freeze dryer series for model sizes and capacity, then contact us with your target shelf area, batch format, and validation requirements.
Ready to discuss your validation pathway?
Tell us your batch format, target shelf area, and regulatory pathway. Our pharmaceutical engineering team will respond within one business day.