Ultra-clean Single-use Filling Assembling

Short Description:

The single-use filling assembling is a pre-assembled, pre-sterilized, and pre-validated aseptic filling unit. It is constructed with a high-level buffer bag (i.e., filling bag), single-use capsule filters, single-use sterile connectors, disconnectors, filling tubing, and single-use filling needles. The single-use filling system does not need CIP, SIP and cleaning validation. This ready-to-use system can achieve quick batch-to-batch switching and provide flexibility for small-batch filling.

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Product Description

● Production Environment
✓ The entire manufacturing process of LePure’s single-use filling assembling performed in a Class C or Class A cleanroom environment, from film cutting, bag manufacturing, to assembling and packaging. Components such as tubing, connecting fittings and filling needles are subjected to an ultra-clean pre-washing and drying process. The process is gone through vigorous validation testing to ensure consistency of high cleanliness. In addition, the products are tested for visible particulates, sub-visible particles, conductivity, total organic carbon, and endotoxin.

● Dispensing Design
✓ The dispensing method of the single-use filling assembling affects filling accuracy. LePure Biotech can design spray or ship-form dispensing types according to customer process requirements. This will improve the filling accuracy and reduce drug solution residue.

● Tubing Selection
✓ Filling pump tubing is the core of the single-use filling system. Selecting a suitable high-precision filling pump tubing can effectively solve problems of unstable or offset filling volume. Liveo APT, Pumpsil or Accusil hoses are selected by LePure Biotech according to the different requirements of filling machine brands.

● Filling Needles
✓ Based on the requirements of Bosch, IMA, Tofflon or Truking filling machines, LePure Biotech has developed a suitable single-use filling needle.