Free material test first
We run your actual powder on our machine and send you sample bags plus a test video — before you pay anything.
Nothing upfront
The 30% deposit is due only after you have seen the test results and approved them.
Balance on acceptance
Final payment is due only after the machine passes its factory acceptance test and you sign off.
Factory direct, 15 years
You work with the manufacturer, not a reseller. Our engineers reply to every enquiry within 1 business day.
GMP Requirements Built In — Not Added On
Most “pharma-grade” fillers are standard food machines with a stainless steel upgrade. That does not meet GMP. A pharmaceutical powder filling machine must be designed for validated cleaning, material traceability, and audit-ready documentation from the first drawing.
Our Pharma Filler Range
- API Micro-Dosing Filler — 10mg–50g fill range, ±0.5% accuracy on cohesive and static-sensitive powders. Isolator-compatible. For potent APIs (OEB 3–4).
- Excipient Bulk Filler — 50g–25kg. Net weight or auger dosing. SS316L contact, Ra ≤0.8µm. For lactose, starch, microcrystalline cellulose, mannitol.
- Finished-Dose Powder Filler — 1g–500g into bottles or pouches. 30–80 fills/min. 21 CFR Part 11 audit trail, user access control, electronic batch record export.
- Isolator-Integrated Filler — Glove-port compatible, VHP-decontamination-ready. Negative-pressure containment. For OEB 4–5 (potent compounds, cytotoxics, hormones).
Fill Mechanisms for Pharma Powders
Three dosing principles cover the full pharmaceutical range. For a deeper breakdown of auger geometry, pitch selection and accuracy limits, see our auger filling machine page.
| Mechanism | Fill Range | Accuracy | Best For | Limitation |
|---|---|---|---|---|
| Vacuum Drum | 10–500mg | ±1–2% | Low-dose, free-flowing | Weight adjustment requires drum change |
| Auger / Dosator | 50mg–5g | ±0.5–1.5% | Cohesive APIs, blends | Bulk density sensitivity |
| Net Weight | 5g–25kg | ±0.1–0.2% | Legal-weight products, validation | Slower, higher cost |
From production experience
The mechanism decision is made on bulk density and flow, not on fill weight alone. A cohesive API that bridges in an auger hopper will not hit ±0.5% no matter how the dosing screw is tuned — which is why we run your actual powder before quoting a mechanism, and send you the sample bags and test video to review.
Validation Package: IQ/OQ/PQ
- IQ (Installation Qualification): Documented verification that the machine is installed per specification — utility connections, environmental conditions, calibration certificate traceability to national standards.
- OQ (Operational Qualification): Documented verification that the machine operates within specified parameters across the full operating range — fill weight, speed, and accuracy tested at low/mid/high setpoints.
- PQ (Performance Qualification): Documented verification with your product — typically 3 batches minimum. We provide the protocol template; your QA signs off.
Cleaning Validation Design
- No hidden cavities: All product-contact surfaces are visible and accessible without tools. No threaded connections in the product zone. Continuous TIG welds, ground flush and polished to Ra ≤0.8µm.
- Tool-free disassembly: Hopper, auger, and fill nozzle remove in under 3 minutes by one operator. No tools required — all tri-clamp connections.
- Riboflavin-tested: All contact surfaces pass riboflavin (vitamin B2) UV fluorescence test — confirms no spray shadow zones during CIP cycle.
- Drainability: All product-contact surfaces are sloped ≥3° toward the drain point. No horizontal surfaces in the product zone.
21 CFR Part 11 Compliance
- User access control: Three-tier — Operator (run recipes), Supervisor (edit recipes, acknowledge alarms), Administrator (system configuration, audit trail review).
- Audit trail: Time-stamped, non-editable record of every parameter change, alarm, and user action. Exportable as PDF for regulatory submission.
- Electronic batch record: Auto-generated per batch — fill weights (min/max/mean/σ), alarm log, user actions, material lot tracking.
- Data integrity: All records stored in encrypted, checksum-verified format. No data can be deleted — only archived per retention policy.
Technical Specifications
| Parameter | Value |
|---|---|
| Fill weight range | 10mg – 25kg (mechanism-dependent) |
| Accuracy | ±0.5–1.5% auger; ±0.1–0.2% net weight |
| Contact material | SS316L, Ra ≤0.8µm, electropolished option (Ra ≤0.4µm) |
| Non-contact structure | SS304, fully welded, crevice-free |
| Seals & gaskets | FDA-compliant silicone (standard); EPDM, Viton, PTFE options |
| PLC | Siemens S7-1500 (21 CFR Part 11 compliant firmware) |
| HMI | 15″ touchscreen, 3-tier user access |
| Containment | Open (OEB 1–2), downflow booth (OEB 3), isolator (OEB 4–5) |
| Cleaning | Manual (standard), CIP-ready (optional) |
| Documentation | IQ/OQ/PQ protocol, FDS, HDS/SDS, FAT/SAT, material certs (3.1), surface finish certs |
| Lead time | 40–65 working days (GMP documentation and validation extend lead time) |
Frequently Asked Questions
Do you provide full IQ/OQ/PQ documentation?
Yes. We provide protocol templates written to ISPE GAMP 5 guidelines. Our commissioning engineer executes IQ/OQ on-site with your QA team. PQ runs with your product — typically 3 validation batches. All documentation is in English; local-language translation available.
Is the machine 21 CFR Part 11 compliant?
Yes — the Siemens S7-1500 controller with audit-trail firmware meets Part 11 requirements for electronic records and signatures. We provide a compliance assessment document mapping each Part 11 subpart to the machine’s control features.
Can the machine handle potent compounds (OEB 4–5)?
Yes — the isolator-integrated model is designed for OEB 4–5 containment. Negative-pressure operation, HEPA-filtered exhaust, VHP-decontamination-compatible, and glove-port access. Containment performance verified by industrial hygiene monitoring (typically under 1µg/m³ 8-hr TWA for OEB 4).
What about material traceability and serialization?
The batch record system captures material lot numbers entered by the operator at batch start. Integration with your MES/ERP (SAP, Siemens Opcenter, Werum PAS-X) is via OPC-UA or XML over TCP/IP. Full serialization is available as an option — requires integration with your Track & Trace system.
How long does validation take?
Plan 3–5 days for IQ/OQ execution on-site plus 3 production days for PQ. Protocol review and approval with your QA team typically takes 2–3 weeks before the site visit. We recommend engaging our validation team 6–8 weeks before your target production date.
What Ships With Every Machine
Documentation and certification are delivered as standard — not quoted as an extra line item.
Validation packageIQ/OQ/PQ protocol templates written to ISPE GAMP 5. Our commissioning engineer executes IQ and OQ on-site with your QA team; PQ runs on your product. FDS, HDS/SDS and FAT/SAT records are included in the same package.
Material & surface certificationEN 10204 3.1 material certificates for every product-contact part, plus surface finish test records — not just the specification. SS316L at Ra ≤0.8µm as standard, electropolished to Ra ≤0.4µm on request.
Compliance evidenceA 21 CFR Part 11 assessment mapping each subpart to the control system, the riboflavin UV cleaning test report for all contact surfaces, and industrial hygiene containment data on isolator-integrated builds.
Further Reading
Request a Factory Direct Quote
GMP-compliant build, full IQ/OQ/PQ package, factory pricing. Free material test on your own powder before you pay anything.