SJ冻干机工厂与车间展示
展示SJ冻干机工厂、装配流程与车间现场，涵盖实验型、中试型、食品冻干及GMP系统。
For US Biotech, CDMOs, and Process Development Labs
GMP Lyophilizers for Emerging Biotech and Small CDMOs
0.5 to 2.16 m² shelf area · 21 CFR Part 11 compliant · 316L contact parts · Validation packages adaptable to lean QA teams · Installed at US biotech sites in Boston, Bay Area, and RTP
Why emerging biotech teams choose us over the major brands
If your IND filing is 12 months away and you're choosing between a $400K system from a major brand or our pilot-scale GMP unit, here's what's actually different. We don't try to compete on legacy. We compete on fit, speed, and price.
| What you usually get from major brands | What we offer |
|---|---|
| $300K – $700K typical pilot system pricing | $60K – $120K range, transparent on our website |
| 4–8 week sales cycle before getting a quote | Budgetary number in 48 hours · No NDA required |
| 6–12 month lead time after PO | 90–150 days from PO to delivery |
| Documentation tailored to large pharma SOPs | Validation packages adaptable to lean QA teams or single CMC consultants |
| Dedicated sales rep, slow technical answers | Direct email access to our process engineers |
| Service contracts starting at $30K/year | À la carte service · Remote SCADA diagnostics standard |
| NDA before sharing technical specs | All technical content available without registration |
See it in action
Product walkaround, SCADA validation, and process highlights — picked from our video library. Admin chooses which clips appear here.
SJ Command 50FT GMP冻干机
SJ Command 50FT GMP冻干机视频，展示中试及生产应用中的搁板载量、腔体布局与设备配置。
SJFreeze Dryer ,shelves loading area is 4.3 sq meters.
SJFreeze Dryer ,F20M Bulk type Freeze dryer
US installations to date
Our pilot-scale GMP systems are currently operating at biotech and CDMO facilities across the major US life science clusters:
- A Series B oncology biotech in the Boston/Cambridge area — pilot-scale unit supporting IND-enabling studies
- A small CDMO in the San Francisco Bay Area — installed in 2025, validation executed by the client's CMC consultant using our IQ/OQ/PQ protocols
- A protein therapeutics startup in the Research Triangle Park area — supporting Phase 1 clinical material production
Client names and detailed case studies are available under NDA after an initial technical call.
21 CFR Part 11: Real implementation, not a checkbox
Many vendors say “21 CFR Part 11 ready.” When your QA team or a regulatory consultant actually opens the SCADA, here's what they'll find on our systems.
- Audit trail: every parameter change, recipe modification, and user action is logged with timestamp, user ID, and reason
- Electronic signatures: dual-factor authentication for critical operations (recipe approval, batch release, deviation acknowledgment)
- User access management: role-based permissions (Operator / Supervisor / QA / Engineer / Admin) with configurable rights per role
- Time stamps: server time synced to NTP source · No local clock manipulation possible
- Data integrity: ALCOA+ principles enforced · No raw data deletion · All edits tracked as new records
- Backup and archival: automated daily backups · 10+ year data retention · Export to PDF or CSV with embedded audit metadata
- Reason for change required: every parameter change requires user-entered justification
Your QA consultant can review the full SCADA via screen-share before purchase. We don't expect you to take our word for it.
Your QA team can request a live SCADA screen-share — every audit trail, electronic signature, and access control feature listed here is operational on systems in use today.
Pilot GMP system specifications
All systems include 21 CFR Part 11 SCADA, 316L product contact parts, and standard validation package. Configurations below are typical; custom requirements (CIP/SIP, stoppering, redundant vacuum, custom shelf temperature range) are quoted separately.
| Model | Shelf Area | Shelf Temp | Condenser | Vacuum |
|---|---|---|---|---|
| Command SJ-50F(T) | 0.5 m² (5.4 ft²) | -65°C to 65°C | ≤-85°C | ≤7.5 mTorr |
| Command SJ-100F(T) | 1.0 m² (10.8 ft²) | -65°C to 65°C | ≤-85°C | ≤7.5 mTorr |
| Command SJ-200F(T) | 2.16 m² (23.2 ft²) | -65°C to 65°C | ≤-85°C | ≤7.5 mTorr |
| Command SJ-300F(T) | 3.2 m² (34.4 ft²) | -65°C to 65°C | ≤-85°C | ≤7.5 mTorr |
| Command SJ-500F(T) | 5.4 m² (58.1 ft²) | -65°C to 65°C | ≤-85°C | ≤7.5 mTorr |
Ultimate chamber vacuum ≤7.5 mTorr (≤1 Pa / 0.0075 Torr) — measured empty, post pull-down, with chamber sealed.
Electrical configuration
Standard configurations: 480V / 60Hz / 3-phase (North America), 400V / 50Hz / 3-phase (EU / Asia), 220V / 60Hz / 3-phase (regional / smaller sites). Other regional voltages available — specify on inquiry.
Validation package: what's actually in the box
Every Command-series GMP system ships with a complete validation documentation set. Below is the standard package. Custom additions (FAT/SAT extensions, PAI rehearsal support, custom URS gap analysis) are available on request.
Documentation
- Design Qualification (DQ) document
- Installation Qualification (IQ) protocol
- Operational Qualification (OQ) protocol with test scripts
- Performance Qualification (PQ) support template
- 21 CFR Part 11 compliance matrix
- Risk Assessment (FMEA) template
- Calibration certificates for all critical instruments
- Material certificates (3.1 for 316L contact parts)
- Welding documentation
Procedures and support
- Factory Acceptance Test (FAT) procedure
- Site Acceptance Test (SAT) procedure
- Standard Operating Procedure (SOP) templates
- User training materials (operator + maintenance)
- Spare parts list with critical-spare recommendations
- Mock-PAI rehearsal support (on request)
- Remote validation execution support
Pricing transparency
Most pilot-scale GMP lyophilizers in North America are quoted between $300K and $700K, with 4–8 week sales cycles before you even see a number. We do this differently.
| Model | Typical Range (USD, FOB Ningbo) | Standard Lead Time |
|---|---|---|
| Command SJ-50F(T) — 0.5 m² | $60K – $70K | 90–150 days |
| Command SJ-100F(T) — 1.0 m² | $75K – $90K | 90–150 days |
| Command SJ-200F(T) — 2.16 m² | $90K – $120K | 90–150 days |
Final pricing depends on configuration: stoppering, CIP/SIP, redundant vacuum, custom shelf temperature range, or non-standard chamber dimensions. Validation package included in all base prices.
Get a budgetary number within 48 hours. No NDA. No 30-minute discovery call. Just a number for your CFO.
Request Budgetary QuoteService commitments — what to expect after PO
Response & communication
- Initial inquiry response: 24 business hours
- Technical proposal turnaround: 5–10 business days
- Quote validity: 60 days
- Direct email access to assigned process engineer
Installation & training
- Onsite installation included in price
- 3–5 days of operator + maintenance training
- Validation execution support (remote or onsite)
- FAT and SAT procedures provided
After installation
- Standard warranty: 12 months parts and labor
- Extended warranty available (24 months)
- Remote SCADA diagnostics included
- Critical spare parts list provided at delivery
- Partnering with US-based service providers for onsite support; case-by-case arrangement
Regular US presence
- Engineering team travels to the US every 2–3 months
- Onsite service visits scheduled around regular travel rotation
- Remote SCADA diagnostics available for urgent issues — no waiting for next trip
- Your assigned process engineer typically meets you in person during installation or validation
- Prospect site visits available — we can meet face-to-face before you commit to a PO
Questions emerging biotech teams ask us
We're a Series A biotech with no formal QA team. Will your validation package be too complex for us to use?
No. We've worked with biotech clients who have a single CMC consultant handling all validation work. Our IQ/OQ/PQ protocols are written to be followed by a small team, with optional remote support during execution. Many clients have a CMC contractor execute the validation against our protocols.
You're based in China. What happens if our equipment has a problem and we need onsite support?
Three layers of support are in place: 1. Remote SCADA diagnostics — included with every system, standard. For ~80% of issues (alarms, parameter tuning, recipe troubleshooting, sensor calibration questions), we resolve remotely within one business day. 2. Regular US travel rotation — our engineering team visits US clients every 2–3 months. Non-urgent onsite work is scheduled around these trips. 3. US-based service partners — for urgent onsite needs that can't wait for our next visit, we coordinate with US-based service technicians on a case-by-case basis. We are actively expanding this network as our US installed base grows. We're transparent that we are not a US-headquartered company with 50 field service engineers. But for emerging biotech teams who value direct access to the actual process engineers who designed their system — rather than navigating a tiered support call center — the model works well. Several of our US clients have specifically cited this as a reason they chose us.
We need to file an IND in 9 months. Can your timeline support this?
Yes, with reasonable timing. Standard lead time is 90–150 days from purchase order to delivery, plus 2–4 weeks for onsite installation and IQ/OQ. Total: roughly 4–6 months. If you place the order in the next 30–45 days, you still have 3–5 months for engineering runs and PQ before your IND date.
What happens if our funding situation changes mid-build?
We work with biotech clients on this realistically. Standard payment schedule is 30% deposit, 60% before shipment, 10% after acceptance. We've accommodated payment delays for clients between funding rounds. Talk to us early if there's a concern.
We don't have an in-house engineer who knows lyophilization. Who do we call when something doesn't work?
Our process engineers are accessible directly by email and scheduled video calls — not gated by a sales rep. Remote SCADA diagnostics is standard. For onsite issues, we coordinate with US-based service providers for hands-on support, with response timelines arranged before installation.
If FDA inspects our facility, will your equipment hold up?
Our GMP design follows 21 CFR Part 11, FDA cGMP for pharmaceutical manufacturing, and PDA Technical Report 39 for lyophilization validation. Our equipment is currently used in IND-enabling studies in the US. We support clients with mock-PAI rehearsals and have resources to assist with FDA Form 483 responses if questions arise.
Why should we pick you over GEA, IMA Life, or SP Scientific?
Honest answer: if budget is unlimited and timeline is flexible, the major brands have decades of FDA inspection history and we don't. If you need GMP-ready equipment that fits an emerging biotech budget and timeline, and you can afford to spend 30 minutes evaluating a newer supplier, we're a serious option. We'd rather have you ask tough questions upfront than be surprised later.
Can you provide reference contacts in the US?
Yes, for serious prospective buyers (typically after a technical scoping call). We facilitate introductions to current US clients in similar applications, subject to their consent. Most current US clients are willing to take a 15-minute reference call.
How do we handle import, customs, and shipping from China?
Standard delivery is FOB Ningbo or CIF US port. We work with experienced freight forwarders who handle the customs process for pharmaceutical equipment regularly. Typical sea freight transit is 25–35 days from departure. We provide all required documentation (commercial invoice, packing list, certificate of origin, technical specifications) for HS code classification and FDA import filing.
Ready to talk specifics?
Two ways to start. Pick whichever fits your timeline.
Schedule a 30-min Technical Call
Talk directly to one of our process engineers. We'll review your application, suggest the right system size, and answer technical questions. No sales pitch.
Book a CallSend a Detailed Inquiry
Fill out a brief form with your application details. You'll receive a budgetary quote and recommended system configuration within 24–48 business hours.
Open Inquiry Form