SteriCraft® · SC-PIS Series
● In stock at 3 depots — 48h delivery
● In stock at 3 depots — 48h delivery
Indicator→
Sterile control systems · in-pack chemical indicators
SteriCraft® Plasma indicator strips — Class 4
Pure-cellulose Class 4 indicator strips for in-pack monitoring of hydrogen-peroxide plasma cycles at 45 – 55 °C, with a decisive green → yellow transition.
CE · EU MDR 2017/745
ISO 11140-1
ISO 13485
Format
200 strips / box · 50 boxes / carton
SC-PIS-C4
Pack: 200 / box
Temp. range: 45 – 55 °C
Class 4
ISO 11140-1
45–55 °C
plasma range
200
strips per box
> 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 | Chemistry | Pack | Temp. range |
|---|---|---|---|
| SC-PIS-C4 | Class 4 · H₂O₂ plasma | 200 / box | 45 – 55 °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
PlacementInside each plasma pack
Reading & release
ReadImmediately at unload
ComparePrinted reference swatch
End-pointGreen → yellow, decisive
RecordLot-traceable cycle log
Performance
Colour contrast
high ΔE
Post-cycle stability
> 12 months
Lot repeatability
QC per lot
03
Where this product is specified
CSSD
Plasma loads
In-pack verification for every H₂O₂ plasma load of heat-sensitive devices.
OT
Endoscopy & MIS
Cameras, scopes and cabled instruments processed at low temperature.
OPH
Ophthalmic & ENT
Micro-surgical device packs verified without heat exposure.
AUD
Audit & tender
Batch code, manufacture date and expiry printed per box.
End-to-end workflow
1
Place
Strip inside each pack
2
Process
Run the H₂O₂ plasma 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 green → yellow transition confirms plasma exposure.
H₂O₂ plasma · SC-PIS
BEFORE · CYCLE START
GREEN
Calibrated initial colour
→
45 – 55 °C
H₂O₂
AFTER · CYCLE PASS
YELLOW
Plasma exposure confirmed
Green → yellow · stable > 12 months for archival records
Per-lot release protocol
QC-01Ink calibration against reference plasma cyclesPass
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.
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-PIS-C4
UNIT
Class 4 · H₂O₂ plasma
Class 4 · H₂O₂ plasma printed strip with reference swatch, class identifier and lot code.
CARTON
200 / box · 45 – 55 °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.
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Specify SteriCraft® Plasma indicator strips — Class 4 on your next tender.
Contact Us
Talk to a specialist
Tender-ready documentation, depot stock, and 48h delivery.