4.5/ 5.0
100% pembeli merasa puas
2 rating • 1 ulasan
5(1)50%
4(1)50%
3(0)0%
2(0)0%
1(0)0%
Atur jumlah dan catatan
Stok Total: Sisa 2
Subtotal
Rp5.700.000
Biological Indikator untuk autoclave, Biological Indicator steam
Rp5.700.000
- Kondisi: Baru
- Min. Pemesanan: 1 Buah
- Etalase: Semua Etalase
Introduction
The monitoring of sterilization condition at preferred places with the help of Self Contained
Biological Indicators (or SCBI) is no longer practice of every day in most European Hospitals.
Whereas outside Europe the SCBI is widely used for daily routine checks for Steam sterilization in
Hospitals SCBI’s are mainly used in Hospitals for validation purposes.
2 Description
The Sterintech Self Contained Biological Indicators are designed to comply with the ISO 11138
standard. Basically it is a bacillus inoculated strip or metal carrier which is packed together with an
ampoule inside the plastic vial and closed / sealed with a lid in which a small filter is placed.
The Sterintech SCBI’s are characterized by the following:
Biological Indicators conform to ISO 11138
* SCBI STEAM: Geobacillus Stearothermophilus ATCC 7953 1x10⁶ spores per vial
* SCBI EO: Bacillus Atrophaeus ATCC 9372 1x10⁶ spores per vial
* SCBI PLASMA: Geobacillus Stearothermophilus ATCC 7953 1x10⁶ spores per vial
* SCBI FORM: Geobacillus Stearothermophilus ATCC 7953 1x10⁶ spores per vial
Color change Media: green to yellow (EO) and purple to yellow (Steam, Plasma and FORM)
Lay-out of the SCBI Ampoule Labels
STEAM Plasma EO FORM
CI: Violet - Green CI: Red - Yellow CI: Red - Yellow CI: Violet - Green
3 Confirmation to standards
The Sterintech SCBI’s are compliant to the following standards:
Biological Indicator: ISO 11138-1 , for EO only ISO 11138-2 and for steam only ISO 11138-3
Pls refer to the attached Certificate of Conformity
4 Raw Materials
The Sterintech Self Contained Biological Indicators consists out of the following materials:
- Tube & Cap: PP , fully recyclable
- Paper strip / Metal: Classified information
- Growth Media: Classified information
- Carton: -
- Box Label: Vellum , non latex glue
- Manual: Paper
- Inks : Water based ink, non toxic.
- Indicators: Indicator Ink, Water based, non solvent, non-toxic, non-heavy metals
5 Quality assurance
The Sterintech Self Contained Biological Indicators are produced in accordance with our
ISO 13485 based procedures. All working instructions and checking methods are laid-down in our
Quality Assurance system which is audited twice a year internally and once year by external
auditors.
All products produced by SP Medikal are traceable by lot numbers. Production files are recorded and
kept for 10 years and by these every product can be traced and linked to raw materials used for the
production of the product.
Re-call procedures are forming a part of our quality manual.
Note :
ISI : 100 PCS
Mohon untuk menanyakan stok terlebih dahulu kepada admin
Setiap pembelian/pemesanan di sertai COA
Untuk pertanyaan lebih lanjut mengenai produk kami bisa hubungi admin kami
Terimakasih
Happy Shopping!!
The monitoring of sterilization condition at preferred places with the help of Self Contained
Biological Indicators (or SCBI) is no longer practice of every day in most European Hospitals.
Whereas outside Europe the SCBI is widely used for daily routine checks for Steam sterilization in
Hospitals SCBI’s are mainly used in Hospitals for validation purposes.
2 Description
The Sterintech Self Contained Biological Indicators are designed to comply with the ISO 11138
standard. Basically it is a bacillus inoculated strip or metal carrier which is packed together with an
ampoule inside the plastic vial and closed / sealed with a lid in which a small filter is placed.
The Sterintech SCBI’s are characterized by the following:
Biological Indicators conform to ISO 11138
* SCBI STEAM: Geobacillus Stearothermophilus ATCC 7953 1x10⁶ spores per vial
* SCBI EO: Bacillus Atrophaeus ATCC 9372 1x10⁶ spores per vial
* SCBI PLASMA: Geobacillus Stearothermophilus ATCC 7953 1x10⁶ spores per vial
* SCBI FORM: Geobacillus Stearothermophilus ATCC 7953 1x10⁶ spores per vial
Color change Media: green to yellow (EO) and purple to yellow (Steam, Plasma and FORM)
Lay-out of the SCBI Ampoule Labels
STEAM Plasma EO FORM
CI: Violet - Green CI: Red - Yellow CI: Red - Yellow CI: Violet - Green
3 Confirmation to standards
The Sterintech SCBI’s are compliant to the following standards:
Biological Indicator: ISO 11138-1 , for EO only ISO 11138-2 and for steam only ISO 11138-3
Pls refer to the attached Certificate of Conformity
4 Raw Materials
The Sterintech Self Contained Biological Indicators consists out of the following materials:
- Tube & Cap: PP , fully recyclable
- Paper strip / Metal: Classified information
- Growth Media: Classified information
- Carton: -
- Box Label: Vellum , non latex glue
- Manual: Paper
- Inks : Water based ink, non toxic.
- Indicators: Indicator Ink, Water based, non solvent, non-toxic, non-heavy metals
5 Quality assurance
The Sterintech Self Contained Biological Indicators are produced in accordance with our
ISO 13485 based procedures. All working instructions and checking methods are laid-down in our
Quality Assurance system which is audited twice a year internally and once year by external
auditors.
All products produced by SP Medikal are traceable by lot numbers. Production files are recorded and
kept for 10 years and by these every product can be traced and linked to raw materials used for the
production of the product.
Re-call procedures are forming a part of our quality manual.
Note :
ISI : 100 PCS
Mohon untuk menanyakan stok terlebih dahulu kepada admin
Setiap pembelian/pemesanan di sertai COA
Untuk pertanyaan lebih lanjut mengenai produk kami bisa hubungi admin kami
Terimakasih
Happy Shopping!!
Ada masalah dengan produk ini?