Application
The 290CF OnDemand HFFS Cold Form Suture Pack Machine is ideal for foil /foil suture packs that require a Tyvek® breather for sterilization process. Eliminates the need for a secondary breather package. Ideal for high SKU, low or mid-range volume applications. Use this machine in conjunction with SelectSeal Post Sterilization Seal/Trim Machine.
Packaging Materials
Material input rollstock lidding
Cold Formable Foil, Foil Lidding and Tyvek ®
Cold Form HFFS Machine for Foil Suture Packaging
The SelectSeal 290CF is a horizontal form-fill-seal machine that cold forms foil suture packs and seals a Tyvek breather into the package in one pass. Because the breather is integrated during forming, there is no need for a secondary breather package to allow sterilant ingress.
Cold forming avoids heat entirely. The cavity is formed with air pressure at up to 170 PSI and no mechanical plugs, which suits foil laminates that cannot be thermoformed without damaging the barrier layer. Foil is among the most expensive materials in medical packaging, and forming without plug contact keeps scrap to a minimum.
Material inputs are cold formable foil for the bottom web, foil lidding for the top web, and Tyvek rollstock for the breather. Maximum web format is 11.4 inches by 4.7 inches, running at up to 20 cycles per minute.
Online digital UV printing applies full colour artwork by recipe, including lot and expiration data, so no secondary printing operation is required. Matched metal tooling trims the breather area and punches locating holes with vacuum slug removal, giving precise hole positions for downstream processing.
The seal station is servo driven at 3000 lb maximum force with direct load cell feedback, and a seal force calibration kit is included. Cognex or Keyence vision inspects printed graphics and variable data. Optional pinhole creation and detection systems are available, along with web cleaning and edge guiding to within 0.5mm.
Output is a 4up suture sheet with a pre-sealed perimeter connecting to the breather and the Tyvek breather sealed to the bottom web. After sterilization the breather is removed and the package finally sealed on a SelectSeal post sterilization seal and trim machine.
- High force forming with air pressure
- In-line on-demand full color printing
- Print online lot and expiration – no secondary printing needed
- Servo-based sealing with direct force feedback verification
- Minimal scrap of high cost foil material
- Precision hole locations for secondary processing
- Simple tool change
- Class 8 cleanroom compatible
- Vision inspection of device, graphics and variable data
- Recipe scan to load with auto tool verification
- Fully validatable, GMP Compliant
- Open software architecture
Machine Specifications
| Typical Configuration | Other Configurations | |
|---|---|---|
| Max Web Format (web width x index) |
11.4″ x 4.7″ (290mm x 120mm) | Other formats readily available |
| Rollstock (Top and Bottom) | 14” (356mm) max dia roll, 3” (76mm) core | Larger diameter roll unwind options available |
| Rollstock (Tyvek®) | 14” (356mm) max dia roll, 3” (76mm) core | Larger diameter roll unwind options available |
| Web Cleaning System (optional) | 2-hood system or no web cleaning | 4 hood web cleaning system and anti-static bars by Static Clean International |
| Web Edge | Coast Controls web edge guiding system | Edge detection within 0.5mm with alarm |
| Rate | Up to 20 Cycles per minute (CPM) | |
| Materials of Construction | Anodized Aluminum Extruded framework, SS, other cleanroom compatible materials | |
| Power (utility) | 240VAC or 480VAC, 3phase, 60hz | Other voltages available |
| Air Consumption (utility) | 80-100PSI air source, CFM to be provided based on actual application | |
| Film Unwind | Powered, constant tension with low roll, web break and splice detect as standard | Dual roll unwind or cart |
| Form Station | High force forming station with air pressure forming. Form air up to 170 PSI available. No mechanical plugs. | |
| Pin Hole Detection (optional) | Space available | Pinhole creation and pinhole detection systems available. |
| Cutting – Breather Hole | Matched metal round corner trim of breather area | |
| Top Web Print | Online digital UV printing, artwork per recipe | Number of colors can be specified |
| Cutting – Locating Hole | Matched metal hole punches trim with vacuum slug removal | |
| Controls | Allen-Bradley PLC and HMI with Yaskawa motion | Other platforms available upon request |
| Seal Station | 3000# max force, servo-based sealing station with direct force load cell feedback for verification. Seal force calibration kit included. | Pneumatic-based sealing available |
| Cutting – XMD | Matched metal straight cut of 4up suture sheet | |
| Final Output Configuration | 4up sheet with sutures, pre-sealed perimeter with connection to breather, Tyvek® breather sealed to bottom web. | Other output configurations available |
| Controls | Allen-Bradley PLC and HMI with Yaskawa motion | Other platforms available upon request |
| Safety | Zero tolerance safety package | |
| Vision | Cognex or Keyence cameras for inspection of printed graphical and variable information | |
| Software Features | Process parameter verification, 4 User security logins, Data change tracking, Line Clearance | Customizable per requirements |
