CertoSeal 200
Validatable continuous sealing device, manual cutting.
- Device type
- Validatable continuous sealing device
- Cutting function
- Manual, for roll stock
- Pouch feed
- Automatic
- Operation
- 7-inch touch display
A pouch is only a barrier while the seal holds.
Even, wide enough, at the right temperature. That is a device, not a technique.
CertoSeal 300
The same device with an automatic cutter.
- Device type
- Validatable continuous sealing device
- Cutting function
- Automatic, for roll stock
- Pouch feed
- Automatic
- Operation
- 7-inch touch display
What a validatable seal has to do.
Four things, and none of them is a matter of taste.
The standard
DIN EN ISO 11607-2 governs the validation of the sealing process; DIN EN ISO 11607-1 sets the requirements for materials and sterile barrier systems, with the EN 868 series alongside it.
The seam
At least 6 mm wide, and at least 3 cm between the seam and the instrument. A good seam is continuous and even, with no channels and no trapped air.
The two parameters
Sealing temperature and contact pressure are the critical ones. A validatable device makes both settable and monitorable. That is what a reproducible, tight seam rests on.
The routine checks
An ink test or seal check, the seam strength and peelability, and the critical parameters. What exactly is required can differ by chamber and country.
Where the two differ.
Two lines, and the second one is the one people miss.
| Function | CertoSeal 200 | CertoSeal 300 |
|---|---|---|
| Continuous feed, automatic pouch feed | Yes | Yes |
| Validatable to ISO 11607-2 | Yes | Yes |
| USB documentation of the seal parameters | Yes | Yes |
| 7-inch touch display, rolls up to 30 cm | Yes | Yes |
| Cutting the roll stock | By hand | Automatic |
| Hands every seal to the practice software | No | Yes |
Both need maintenance after 30,000 seals at the latest or every 24 months, and revalidation every 12 months.
The cycle ends. The shelf life starts.
In an ordinary drawer, sealed instruments stay sterile for about six months; with dust protection, up to five years. Single or double sealed makes no difference. What matters is that the packaging is intact.
Where they stand
- Dental practices
- General and specialist practices
- Veterinary practices
- Eye and hair clinics
- Clinics
Which one do you need?
Both are validatable and seal the same. The 300 cuts the roll stock itself and hands every seal to your practice software. That is what you are choosing between. We answer, and pass your enquiry to your dealer.