SteriCraft® · SC-BD Series
● In stock at 3 depots — 48h delivery
● In stock at 3 depots — 48h delivery
Indicator→
Sterile control systems · daily air-removal test
SteriCraft® Bowie-Dick test pack
Ready-to-use Class 2 Bowie-Dick test pack for the daily air-removal and steam-penetration test of pre-vacuum autoclaves — blue → black across the full test sheet.
CE · EU MDR 2017/745
ISO 11140-4
EN 285
ISO 13485
Format
Run daily, before the first processed load
SC-BD-134
Pack: 20 packs / box
Note: Single-use
Class 2
ISO 11140-4
134 °C
3.5 min test cycle
Daily
before first load
Full-sheet
uniform colour read
20
packs per box
01
Product information & specifications
All values typical · CoA per lot on request| Product code | Format | Pack | Note |
|---|---|---|---|
| SC-BD-134 | Test pack · 134 °C / 3.5 min | 20 packs / box | Single-use |
| SC-BD-SHT | Replacement test sheets | 100 sheets / box | For reusable holder |
Custom formats available on request. MOQ applies for non-standard specifications.
Test pack build
SheetCalibrated indicator, full-bleed print
BodyPorous paper stack, standardized density
WrapDisposable, ready to place
ReadUniform black = pass
What it detects
Air removalResidual air pockets
Steam penetrationInto a standardized porous load
SuperheatingUneven colour development
LeaksVacuum-system faults
Performance
Colour uniformity
pass criterion
Sensitivity to air
per EN 285
Read simplicity
single glance
03
Where this product is specified
CSSD
Daily release test
First cycle of the day on every pre-vacuum steam sterilizer.
ENG
Commissioning
After installation, relocation or repair of an autoclave.
AUD
Audit evidence
Dated, uniform test sheets filed as objective daily records.
DEN
B-class benchtop
Compact pack fits small-chamber B-class autoclaves.
End-to-end workflow
1
Place
Pack over the drain, empty chamber
2
Run
134 °C · 3.5 min test cycle
3
Remove
Take out the test sheet
4
Read
Uniform colour = pass
5
Log
Date, sign and file
6
Release
Sterilizer cleared for the day
04
Quality control & assurance
Audited under ISO 13485 : 2016 · QC release per lot
Test-sheet read — pass criterion
A passing test develops a uniform colour across the entire geometric pattern. Any pale centre indicates residual air — the sterilizer fails the day's release.
Test sheet · full-bleed print
BEFORE · CYCLE START
BLUE
Printed test sheet
→
134 °C · 3.5 min
STEAM
AFTER · CYCLE PASS
BLACK
Uniform development · pass
Blue → black, uniform across the sheet · pale centre = fail
Per-lot release protocol
QC-01Indicator print calibration per lotPass
QC-02Pack density verification (EN 285 equivalence)Pass
QC-03Pass / fail contrast samplingPass
QC-04Sheet archival stability checkPass
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 11140-4
ISO 11140-4
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 packs sealed until use
Flat
store horizontally, no compression
Single use
one pack per test cycle
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-BD-134
UNIT
Test pack · 134 °C / 3.5 min
Test pack · 134 °C / 3.5 min single-use test pack with full-bleed calibrated sheet and date-entry fields.
CARTON
20 packs / box · Single-use
20 packs per box, 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.
Steam indicator strips — Class 4 · 5 · 6SC-SIS Series
Steam indicator tapeSC-SIT Series
Sterilization wrapping crepe paperSC-CP Series
Specify SteriCraft® Bowie-Dick test pack on your next tender.
Contact Us
Talk to a specialist
Tender-ready documentation, depot stock, and 48h delivery.