Pharmaceutical Powder Filling Machine

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 reviewed cleaning; HEPA-filtered laminar air flow over the fill zone; 21 CFR Part 11 reviewed electronic batch records and audit trail; calibrated servo drives for reviewed dose accuracy (by RFQ 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, reviewed 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 projects, the documentation scope may include DQ files, FAT protocol and report, SAT protocol, IQ/OQ test record templates, PQ support documentation, calibration records, change-control templates and deviation forms. GMP documentation format and FDA 21 CFR Part 11 data-logging requirements are reviewed according to site SOPs and the final technical agreement.

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 reviewed format sets.

GMP open-fill (OEB 1–2) pharmaceutical auger filler, 0.5–500g, 20–60 units/min: scope-based quotation. Closed RABS system (OEB 3) with containment and 21 CFR Part 11: scope-based quotation. Fully contained isolator system (OEB 4–5) with nitrogen purge: scope-based quotation. 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.