Single-use assemblies

Fill/finish single-use assemblies

Overview

Fill/finish single-use assemblies

WMArchitectTM fill/finish single-use assemblies safeguard your therapeutic during the filling process with a wide range of sterility-assured assembly configurations.

Fill/finish single-use assemblies are custom manufactured, pre-assembled and packaged in Watson-Marlow ISO 14644-1 Class 7 cleanrooms. They consist of a large suite of components, all lot traceable and carry an ISO 11137 sterility assurance claim.

Representative assemblies are routinely tested for bioburden, particulates and endotoxin. Where further assurance is needed, our validation experts can provide lot release testing to meet your quality requirements.

Features and benefits

  • Complete confidence in product quality
  • Designed to reduce your validation burden
  • Support of internal validation protocols
  • Product quality assurance with 10-6 SAL (sterility assurance level)
  • Flexible integration with an open architecture approach
  • Use in conjunction with Watson-Marlow peristaltic pumps or Flexicon filling systems for an end-to-end fluid management solution
  • Supply security with Watson-Marlow’s global manufacturing and supply network

Technical summary

Certification and complianceADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI 
SterilitySterile (10-6 SAL) 

Technical Summary table lists features available within the range. See ‘Specifications’ tab for model specific information.

Specifications

Technical specifications

Fill/finish for Flexicon - PF7+Fill/finish for Flexicon - PF7+ with BagFill/finish for Flexicon - QC12/QC14Fill/finish for Flexicon - QC12/QC14 with Bag
Certification and complianceADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI ADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI ADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI ADCF, ISO 14644-1 Class 7, ISO 9001, ISO10993, USP Class VI 
SterilitySterile (10-6 SAL) Sterile (10-6 SAL) Sterile (10-6 SAL) Sterile (10-6 SAL) 

Literature

Brochures

  1. WMArchitect Brochure (US).pdf
    PDF - 1.1mb

Datasheet

Order Information

Order Information

In 2024 we discontinued our AsepticSU TM brand of assemblies for Fleixcon Filling Equipment. Those configurations are now provided under our WMArchitectTM brand. The table below lists the old standard AsepticSU part numbers and corresponding new WMArchitect part numbers that are now available for purchase. For additional information please contact your local Watson-Marlow representative.

Legacy AsepticSU Part Number Corresponding WMArchitect Part Number
Filter
0.2μm with Ø6ID Accusil tubing and MPC connector 80F.0002.A01 33-2023-004001
Configuration A
Ø0.8ID Accusil tubing and PEI nozzle 8PA.0008.A02 33-2023-001002
Ø1.2ID Accusil tubing and PEI nozzle 8PA.0012.A03 33-2023-001003
Ø1.6ID Accusil tubing and PEI nozzle 8PA.0016.A04 33-2023-001004
Ø3.2ID Accusil tubing and PEI nozzle 8PA.0032.A05 33-2023-001005
Ø4.8ID Accusil tubing and PEI nozzle 8PA.0048.A06 33-2023-001006
Ø6.0ID Accusil tubing and PEI nozzle 8PA.0060.A07 33-2023-001007
Configuration B
1L - Ø0.8ID Accusil tubing, MPC connector and PEI filling nozzle 8PB.0108.A30 33-2023-002030
1L - Ø1.2ID Accusil tubing, MPC connector and PEI filling nozzle 8PB.0112.A31 33-2023-002031
1L - Ø1.6ID Accusil tubing, MPC connector and PEI filling nozzle 8PB.0116.A32 33-2023-002032
1L - Ø3.2ID Accusil tubing, MPC connector and PEI filling nozzle 8PB.0132.A33 33-2023-002033
5L - Ø0.8ID Accusil tubing, MPC connector and PEI filling nozzle 8PB.0508.A34 33-2023-002034
5L - Ø1.2ID Accusil tubing, MPC connector and PEI filling nozzle 8PB.0512.A35 33-2023-002035
5L - Ø1.6ID Accusil tubing, MPC connector and PEI filling nozzle 8PB.0516.A36 33-2023-002036
5L - Ø3.2ID Accusil tubing, MPC connector and PEI filling nozzle 8PB.0532.A37 33-2023-002037
5L - Ø4.8ID Accusil tubing, MPC connector and PEI filling nozzle 8PB.0548.A38 33-2023-002038
5L - Ø6.0ID Accusil tubing, MPC connector and PEI filling nozzle 8PB.0560.A39 33-2023-002039
10L - Ø1.6ID Accusil tubing, MPC connector and PEI filling nozzle 8PB.1016.A44 33-2023-002044
10L - Ø3.2ID Accusil tubing, MPC connector and PEI filling nozzle 8PB.1032.A45 33-2023-002045
10L - Ø4.8ID Accusil tubing, MPC connector and PEI filling nozzle 8PB.1048.A46 33-2023-002046
10L - Ø6.0ID Accusil tubing, MPC connector and PEI filling nozzle 8PB.1060.A47 33-2023-002047
Configuration C
5L - Ø0.8ID Accusil tubing, MPC connector and 2 PEI filling nozzles 8PC.0508.A40 33-2023-003040
5L - Ø1.2ID Accusil tubing, MPC connector and 2 PEI filling nozzles 8PC.0512.A41 33-2023-003041
5L - Ø1.6ID Accusil tubing, MPC connector and 2 PEI filling nozzles 8PC.0516.A42 33-2023-003042
5L - Ø3.2ID Accusil tubing, MPC connector and 2 PEI filling nozzles 8PC.0532.A43 33-2023-003043
10L - Ø1.6ID Accusil tubing, MPC connector and 2 PEI filling nozzles 8PC.1016.A48 33-2023-003048
10L - Ø3.2ID Accusil tubing, MPC connector and 2 PEI filling nozzles 8PC.1032.A49 33-2023-003049
10L - Ø4.8ID Accusil tubing, MPC connector and 2 PEI filling nozzles 8PC.1048.A50 33-2023-003050
10L - Ø6.0ID Accusil tubing, MPC connector and 2 PEI filling nozzles 8PC.1060.A51 33-2023-003051

Recommended Products

  1. PF7/PF7+ table top filler

    PF7/PF7+ table top filler

    Tabletop aseptic filling machine for <0.2 ml to >250 ml. Accuracy of ±0.5 % on most volumes prevents costly overfilling.

    Aseptic filling - benchtop fillers

  2. FlexFeed 15/20

    FlexFeed 15/20

    Highly flexible solution for filling with no format parts for different vials/bottles up to 78 mm diameter.

    Aseptic filling - semi-automatic handling

  3. Accusil tubing

    Accusil tubing

    Tubing for accurate filling with excellent dispensing accuracy ± 0.5 %. Eight sizes available.

    Single-use assemblies

Related Products

  1. Validation testing

    Validation testing

    The WMArchitectTM single-use solutions range is fully supported by our experienced validation testing specialists.

    Single-use assemblies