SteriCraft® · SC-SIS Series
● In stock at 3 depots — 48h delivery
● In stock at 3 depots — 48h delivery
Indicator→
Sterile control systems · in-pack chemical indicators
SteriCraft® Steam indicator strips — Class 4 · 5 · 6
Pure-cellulose indicator strips for in-pack monitoring of steam sterilization — Class 4 multi-variable, Class 5 integrating and Class 6 emulating chemistries per ISO 11140-1.
CE · EU MDR 2017/745
ISO 11140-1
ISO 13485
Class & chemistry
200 strips / box · 50 boxes / carton
SC-SIS-C4
Pack: 200 / box
Temp. range: 121 – 134 °C
4 · 5 · 6
ISO 11140-1 classes
200
strips per box
121–134 °C
steam range
> 12 mo
stable post-cycle colour
250 g/m²
pure cellulose carrier
01
Product information & specifications
All values typical · CoA per lot on request| Product code | Class | Pack | Temp. range |
|---|---|---|---|
| SC-SIS-C4 | Class 4 · multi-variable | 200 / box | 121 – 134 °C |
| SC-SIS-C5 | Class 5 · integrating | 200 / box | 121 – 135 °C |
| SC-SIS-C6 | Class 6 · emulating | 200 / box | 121 – 134 °C |
Custom formats available on request. MOQ applies for non-standard specifications.
Strip composition
CarrierPure-cellulose paper, 250 g/m²
InkWater-based · non-migratory
PrintReference scale + class ID
PlacementPoint of greatest sterilant resistance
Reading & release
ReadImmediately at unload
ComparePrinted reference swatch
End-pointDecisive — no ambiguity
RecordLot-traceable cycle log
Performance
Colour contrast
high ΔE
Post-cycle stability
> 12 months
Lot repeatability
QC per lot
ISO 11140-1 class hierarchy — where each SteriCraft® indicator fitsSwipe to see all columns
Class
Type
Reacts to
Typical use
SteriCraft®
Class 1
Process
Exposure to a process
External pack labels
Indicator tape
Class 2
Specific tests
Single variable (Bowie-Dick)
Daily air-removal test
B-D test pack
Class 4
Multi-variable
≥ 2 critical variables
Routine in-pack monitoring
SC-SIS-C4
Class 5
Integrating
All variables to BI equivalence
Load-release on every load
SC-SIS-C5
Class 6
Emulating
All variables of a specified cycle
Cycle-specific validation
SC-SIS-C6
03
Where this product is specified
CSSD
Every wrapped pack
Placed inside each pack at the point of greatest sterilant resistance.
OT
Load release
Class 5 integrating strips support load-release decisions on every load.
DEN
Benchtop autoclaves
Class 4 strips verify small-chamber cycles in clinics and dental practice.
AUD
Audit & tender
Batch code, manufacture date and expiry printed per box for audit trails.
End-to-end workflow
1
Place
Strip inside each pack
2
Process
Run the steam cycle
3
Unload
Read immediately
4
Compare
Against reference swatch
5
Release
Decisive pass / fail
6
Archive
File in the cycle log
04
Quality control & assurance
Audited under ISO 13485 : 2016 · QC release per lot
Colour-change reference — read at unload
Read the strip at unload and compare against the printed reference swatch. The transition is decisive — no ambiguous intermediate state at a passing cycle.
Steam · SC-SIS
BEFORE · CYCLE START
LIGHT BLUE
Calibrated initial colour
→
121 – 132 °C
STEAM
AFTER · CYCLE PASS
BLACK
All variables satisfied
Formaldehyde · SC-FC
on request
BEFORE · CYCLE START
RED
Calibrated initial colour
→
60 – 80 °C
FORM
AFTER · CYCLE PASS
GREEN
FORM exposure confirmed
Light blue → black · calibrated end-point, repeatable across batches. Formaldehyde strips (SC-FC) supplied on request.
Per-lot release protocol
QC-01Ink calibration against reference cycles per lotPass
QC-02End-point colour repeatability samplingPass
QC-03Post-cycle colour stability (> 12 months sealed)Pass
QC-04Non-toxic, non-migratory ink verificationPass
QC-05Box print check — batch, manufacture, expiryPass
Certificate of Analysis issued per lot.
Operating range — at a glance
20 °C40 °C60 °C80 °C100 °C120 °C
Plasma 45 – 55 °CFORM 60 – 80 °CSteam 121 – 134 °C
Stated ranges represent typical hospital cycle profiles. Always validate against the receiving facility's process validation. Strips are single-use only.
05
Certifications & regulatory standing
CE
CE Marking
Conformity with applicable EU requirements for medical devices.
MDR
EU MDR 2017/745
Compliance with the European Medical Device Regulation.
ISO 13485
ISO 13485 : 2016
Manufactured under a certified medical-device QMS.
ISO 11140-1
ISO 11140-1
Product-specific performance and packaging standard compliance.
ProDr regulatory standing — Pakistan & exportcarried by every lot
DRAP ELI 00850
Establishment licence + Class A device registrations
Establishment licence + Class A device registrations
DSLA · DHO ISB
Drug sale licence for lawful distribution
Drug sale licence for lawful distribution
FBR · NTN 4053194-5
Sales-tax registered · active filer
Sales-tax registered · active filer
FSC
Free Sale Certificates for export trade
Free Sale Certificates for export trade
ISO 13485 : 2016
Manufacturing QMS certification
Manufacturing QMS certification
ICCI
Chamber of commerce membership
Chamber of commerce membership
Documentation on request. CoC, CoA, FSC, ISO certificate and full technical dossier — sent to your submitted email or WhatsApp after a short enquiry. No direct downloads.
06
Shelf life & storage
Validated shelf life — 5 years unopened, under controlled conditions
lot expiry printed on every unit
manufacture
lot printed expiry
5 years max
20 – 25 °C
storage temperature
< 60 % RH
relative humidity ceiling
Sealed box
keep unused strips sealed
No sterilants
store away from chemical vapours
Single use
one strip per pack
Do not use if damaged. Inspect packaging integrity before each use; dispose of any unit with compromised seals, tears, or moisture exposure.
07
Packing details
for the selected option: SC-SIS-C4
UNIT
Class 4 · multi-variable
Class 4 · multi-variable printed strip with reference swatch, class identifier and lot code.
CARTON
200 / box · 121 – 134 °C
200 strips per box · 50 boxes per export carton, batch + expiry printed per box.
DELIVERY
Depot stock · 48h
Stocked at Islamabad, Lahore and Karachi depots; palletized shipping and DDP delivery to hospital stores on request.
Plasma indicator strips — Class 4SC-PIS Series
Bowie-Dick test packSC-BD Series
Steam indicator tapeSC-SIT Series
Specify SteriCraft® Steam indicator strips — Class 4 · 5 · 6 on your next tender.
Contact Us
Talk to a specialist
Tender-ready documentation, depot stock, and 48h delivery.