Our Systems’ FAQ

Diecutting Parts In a Clean Room Environment

EXTERNALLY

FDA-registered, ISO 13485 certified consulting and contract laboratories provide validated die cleaning, packaging and sterilization processes compliant with FDA and ISO standards and guidelines. These laboratories can conduct all product specific release testing to meet your requirements, i.e. sterility testing, bacterial endotoxin (LAL) testing, particulate testing, and cytotoxicity.

INTERNALLY

BioCut Systems’ medical dies are made to withstand all methods of medical cleaning (e.g. Autoclave, Heat Convection, High Pressure Medical Washing, etc.)

BioCut Systems makes easy to clean die cutting presses that are clean room compatible by building them with medically safe materials. The presses are made with harsh cleaning agents in mind, smooth surfaces, rounded corners, and no collection areas. These presses won’t rust nor leave particulates.

Biocut Systems manufactures fully pneumatic presses, ensuring no fluid contamination from the machine, like hydraulic presses. All press enclosures are water resistant and work in wet or dry cutting environments.

BioCut Systems’ presses should fit through a standard doorway, and occupy as little space as possible. Maneuverability may be an added value.

Basic level typical uses: cloths, plastics, masks, meshes

Purposes:

  • Die will be used over and over agin
  • Does not need to be cleaned between uses
  • Does not need to be sterilized before the first use
  • No sterilization required
  • Not for use on wet products

Construction:

  • Made of an FDA approved base (acrylic is never acceptable) or specially coated wood
  • Can be lasered but all contact areas must be cleaned
  • Can have rubber ejection
  • Can be normal coated steel rule or stainless but not your typical rule

Moderate level typical uses: bandages, collagen, wipes, foams

Purposes:

  • Die will be used several times, or in some cases it may be considered disposable (because of the lower cost of machined dies it can be more cost effective to throw them away versus re-sterilizing them)
  • Considered FDA approved for cutting non-wet materials, or for single day use for wet materials
  • May need to be cleaned between uses
  • Can be sterilized before the first use
  • Can be used on wet products
  • Low cost alternative to hard tooling
  • This tool is the only one that can be heat convection sterilized effectively

Construction:

  • Made of an FDA approved base or specially treated aluminum
  • Cannot be lasered or waterjet as they both contain contaminants
  • Can have ejection with custom made ejector plates and springs or poke holes
  • Must be made with stainless rule and sometimes that rule must be further processed before knifing, if it will get wet or cleaned in an autoclave

Premium level typical uses: bio materials, skin grafts, bone grafts, tendons, heart valves, medical meshing

Purpose:

  • Die will be used over and over again Needs to be sterilized between uses
  • 100% guarantee of zero contamination from construction to storage to use
  • Made for wet products
  • Can be stored in a sterile liquid and cleaned with a mild acid

Construction:

  • Made only from stainless steel 316L No ejection or moving parts allowed
  • Poke holes and stripper systems may be incorporated into production line Multi-level processing of stainless is required to prevent it from rusting
  • Special de-burring makes dies free of any particulates that may break off of die and lodge into the material being cut
  • Certain coatings may be applied for the same reason of keeping any particulates from the die entering the material for instance of cutting bone grafts