page_banner

Products

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.


Basic information

Download

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.

Ultra-clean Single-use Filling System3
Ultra-clean Single-use Filling System2

● 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.

Ultra-clean Single-use Filling System4

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

Ultra-clean Single-use Filling System6
Ultra-clean Single-use Filling System5

  • Previous:
  • Next:

  • Brochures

    • DownloadDownload
      Data-EN-Single-use Filling Assembling-20220803

    Send your message to us:

    Write your message here and send it to us

    related products