Llenadora farmacéutica

A pharmaceutical powder filling machine meets cGMP (current Good Manufacturing Practice) requirements including: SUS316L stainless steel for all product-contact surfaces (AISI 316L, Ra ≤0.8 µm surface finish); no dead zones or crevices where powder can accumulate; CIP (clean-in-place) or SIP (sterilise-in-place) capability for validated cleaning; HEPA-filtered laminar air flow over the fill zone; 21 CFR Part 11 compliant electronic batch records and audit trail; calibrated servo drives for validated dose accuracy (±0.3% or better); and full IQ/OQ/PQ validation documentation support from our engineering team.

OEB (Occupational Exposure Band) classifies the hazard of the Active Pharmaceutical Ingredient (API) being handled: OEB 1 (nuisance, >1mg/m³) — open fill on standard machine, simple dust extraction. OEB 2 (low hazard, 0.1–1mg/m³) — contained fill with bag-in/bag-out dust extraction. OEB 3 (moderate hazard, 10–100µg/m³) — closed RABS (Restricted Access Barrier System), glove ports. OEB 4 (high hazard, 1–10µg/m³) — isolator with pressure cascade. OEB 5 (highly potent, <1µg/m³) — fully contained isolator, continuous liner, glove-bag transfer. Contact us with your API's OEL (Occupational Exposure Limit) to specify the correct containment level.

Yes. Our pharmaceutical powder filling machines handle a broad range of API physical forms: free-flowing granules and beads (auger dosing, no agitation needed); cohesive fine powders (anti-bridging agitator, vibration funnel, heated fill tube); lyophilised (freeze-dried) powders (gentle handling, validated fill weights); effervescent powders (humidity-controlled fill chamber, rapid seal cycle). For very potent or toxic APIs, the fill system operates inside an isolator with nitrogen purge and integrated solvent-free decontamination. Request a powder characterisation assessment from our applications team.

For pharmaceutical regulatory compliance, HEMUfill provides: Design Qualification (DQ) documentation; Factory Acceptance Test (FAT) protocol and report; Site Acceptance Test (SAT) protocol; IQ (Installation Qualification) protocol and test record templates; OQ (Operational Qualification) protocol and test record templates; PQ (Process Qualification) support documentation; calibration certificates for all load cells, encoders and sensors; change control and deviation form templates. All documentation is delivered in GMP-compliant format and can be customised to your site SOPs. FDA 21 CFR Part 11 compliant data logging is included as standard.

HEMUfill pharmaceutical powder filling machines support multiple fill formats via interchangeable format kits: HDPE/glass bottles (2ml – 2L) — most common for vitamins, supplements, OTC products; sachets and stick packs (0.5g – 30g) — ORS, antacid, pain relief sachets; hard gelatine capsule filling (000 – 5 size) — with capsule orientation and reject station; foil-lidded cups and trays — unit dose OTC; vials (2ml – 100ml) — with fill and stopper crimping optional; bulk fill into drums or IBCs — for upstream process filling. Changeover between formats is tool-free with validated format sets.

GMP open-fill (OEB 1–2) pharmaceutical auger filler, 0.5–500g, 20–60 units/min: from $45,000–$90,000 USD. Closed RABS system (OEB 3) with containment and 21 CFR Part 11: $100,000–$200,000 USD. Fully contained isolator system (OEB 4–5) with nitrogen purge: $250,000–$500,000 USD. Prices include FAT and IQ/OQ templates. Full validation package and SAT support are available as a service add-on. Contact us with your API OEB level, fill weight range and regulatory market (FDA/EMA/local GMP) for a detailed proposal.