Assembly

SteriPack Contract Manufacturing provides many methods for end-users to purchase and receive products and parts. A simple or a complex multi-component product with assembly required, will be conducted from the concept to the product launch.

Starting off small to a big full-scale production run, SteriPack Group share their expertise and ideas for optimisation of the assembly process while finding the most competitive solution.

Manual assembly

Manual assembly systems are typically individual workbenches for each stage in the assembly process. The product gets passed manually from station to station singularly or in batches. However, there are many variations to manual assembly. For example, you could also use a singular assembly line with a manual transfer conveyor. In this case, workers stand at a specific station along the belt and manually push the product down the line as it’s being assembled. This is usually done in lower volumes rather than production runs.

Semi-automatic assembly

Semi-automatic systems are probably the broadest part of the assembly system spectrum. These may include minimum help from an operator, such as manually loading and/or unloading the entire system. Or it can involve a great deal of labour, such as manual checks at every station to allow an automated conveyor to continue down the assembly line. The key for this assembly type is that it includes both manual functions as well as machine-aided assembly.

Automated assembly

Fully automatic systems are solutions that require no human interaction. This means the product is loaded into feed systems or can be transferred from another system that will automatically load into the next step of the assembly process. The automated system then completes the entire assembly including testing, inspection and unloading. If there is human interaction, it can be as simple as responding to system prompts.

Other assembly methods used in SteriPack:

  •  Bonding
  •  Crimping
  •  Kit packaging

All assembly processes are ISO 13485 and FDA requirements compatible. We follow good manufacturing practice for medical devices. Our operational excellence programme includes:

  •  Continuous manufacturing flow
  •  Visual process controls
  •  Documented employee training for our highly skilled operators and technicians
  •  Travel and line history report generated for each build
  •  Dedication to the principles of lean manufacturing and 5S
  •  Kanban for fast response and lower inventories
  •  Kaizen for cost reduction and performance requirements

Some of the key features in our assembly and packaging process include:

  •  Cleanroom assembly in both Class (7) 10,000 and Class (8) 100,000 environments
  •  Manufacturing pilot lines to debug, analyse, validate compliance and finalise for production
  •  Process Failure Mode and Effect Analysis (FMEA)
  •  Epoxy UV curing assembly, mechanical assembly, part pouching and sealing, and tray sealing from sub assembly to delivered, finished, sterile devices
  •  Verification and validation testing; tensile, compression, and torque testing; leak testing by pressure decay and flow rate
  •  Heat staking and ultrasonic welding

Typical application areas:

medical devices elements and whole ready to use devices.

Medical device cleanroom assembly