Filling and closing compact machine for powders.
Powder filling from 2 ÷ 1,500 mg. / Dosing accuracy of ±0.5 ÷ 2% / Output up to 6,000 uph. / Conforms with cGMP - US FDA.
The equipment we present is a compact filling and closing machine for automatic processing of vials and bottles in glass, plastic, or metal, for powders in sterile areas.
The design has been made in compliance with the regulations of the cGMP and US FDA, in special accordance with the requirements of the pharmaceutical and biotech industries.
Production speed: up to 6,000 uph.
The filling station is equipped with volumetric fill guns; the dosing is carried out through vacuum-pressure system, which offers the following advantages:
- Flexibility in processing of complex powders.
- Excellent dosing accuracy of ±0.5 ÷ 2% for most applications.
- Dosing from the bottom of the container to avoid dispersion of powder into the atmosphere.
Powder filling from 2 ÷ 1,500 mg.
The closing station is equipped with a pneumatic crimping head. Optionally, the closing process can be done with a tangential rolling head, characterised by the minimum generation of particles during the closing process.
All closures currently used can be easily handled, such as:
- Rubber stoppers.
- Aluminium caps / Flip-off caps.
The changeover to a different format is carried out quickly, easily and without tools, by exchanging complete sets of format parts.
Feeding of the closures is done automatically by vibrating feeders, made of AISI-316L stainless steel.
In order to work in sterile or clean room applications, DARA Pharma provide different solutions, such as LAF, RABs, or isolators. The generated sterile air ensures a permanent and reliable expulsion of particles and microorganisms from the working area.
Using an isolator or RABs system improves the sterily conditions and offers a better protection of the product and for the user, according to pharmaceutical standards.
This equipment is suitable for clinical trials or medium production batches.
- Dosing control through micro scale and automatic recalibration of the volume to be dosed.
- Gas flushing before, during, or after the filling process.
- Tangential rolling head.
- Automatic rejection of defective vials.
- Data recording software to export the production data in compliance with 21CFR part 11.
- Laminar flow unit / RABs / Isolator unit.
- IQ / OQ Validation package.
- Printing / Codification.