SM-PF
Peristaltic filling
0.1–100 ml±0.5% at 1 ml
Single-use tubing sets, 2 / 4 / 6 heads. Nothing but the tubing touches the product.
Aseptic filling lines for vials, syringes and cartridges
Peristaltic and rotary piston filling, capping and crimping.
±0.5% at 1 ml · 2R–100R vials
±0.5%fill accuracy at 1 ml, per head, on the buyer’s own recipe
99.8%media-fill pass rate over three consecutive runs
24,000units per hour on the largest line we build
6container formats closed in house — vials to pump bottles
/ How the lines run
Numbers the lines run to
Filling, closing and crimping inside one laminar-flow tunnel.
Every line is media-filled on your own containers before it ships.
Read the full specification setFour machine families
SM-RP
Rotary piston filling
2–500 ml60–300 units/min
8 or 12 heads, servo driven. One format change in under 45 minutes.
SM-CC
Capping and crimping
13 / 20 mm caps0.5–6 N·m
In-line checkweigh, reject lane, torque recorded per container.
SM-IS
Isolator and RABS
ISO 14644-1 Class AVHP cycle
Glove-port and rapid transfer port, laminar-flow tunnel through to the capper.
Formats the lines close
The first thing a buyer checks is whether the line runs their container.
/ 01
Vials and ampoules
2R–100R · 1–20 ml · aluminium flip-off caps 13 / 20 mm
/ 02
Pre-filled syringes and cartridges
0.5–20 ml · nested or bulk · plunger placement in-line
/ 03
Ophthalmic and cosmetic bottles
3–500 ml · droppers, pumps and sprayers
Media fill before shipment
99.8%media-fill pass rate
3consecutive runs per line
0interventions per 1,000 units
/ Validation and standards
- EU GMP Annex 1
- ISO 14644-1 Class A / B
- ISO 9001:2015
- CE, Machinery Directive 2006/42/EC
- 21 CFR Part 11
- EN 10204 3.1
/ Factory
The plant in Ruian
2009founded in Ruian, Wenzhou
14,200 m²machining, assembly and FAT halls
26aseptic lines shipped a year
61%exported, mostly to the EU and North America
Export markets — Germany · Italy · Poland · United States · Canada · Singapore · India · Brazil · Mexico
/ Before you enquire
Questions buyers ask first
What is the smallest batch you can run?
From 2,000 units per batch. One format change takes under 45 minutes, and single-use sets remove the cleaning step between batches.
Single-use tubing or stainless steel product path?
Both. Peristaltic filling keeps the product in a single-use set qualified with your process; rotary piston uses a 316L path, Ra ≤ 0.4 µm, clean-in-place.
How is the media fill recorded?
Three consecutive runs on your containers and recipe, with particle counts, the intervention log and video per run.
Isolator or RABS — which one do we need?
It follows your cleanroom class: a VHP isolator for a Class C background, RABS for an existing Class B room.
What is in the documentation package?
IQ/OQ protocols, EN 10204 3.1 certificates, Ra ≤ 0.4 µm surface reports, FAT records and the spare-parts list.
What are the lead times?
90–120 days for single machines, 180–240 days for complete lines from the signed drawing.
/ Request a line
Send your container, get a line
Process review and quote within 5 working daysFAT with your containers before shipment