Biological Indicator for Steam

Biological Indicator for Steam Specification

Size
Standard

Equipment Type
Biological Indicator for Steam

Suitable For Use
Hospital, Laboratory, Pharmaceutical, Medical Device Sterilization

Technology
Steam Sterilization Monitoring

Portable
Yes

Material
Polypropylene tube with spore strip and growth media ampoule

Application
Steam Sterilization Process Monitoring & Validation

Use
Sterilization Validation

Storage Instructions
Store between 2C 25C, dry condition

Color
Clear tube, purple or clear media

Capacity
One per cycle/test

Function
Detects presence or absence of viable bacterial spores post sterilization

Condition
New

Shape
Cylindrical Ampoule

Real-Time Operation
No

Operation Mode
Incubation Post Exposure

Operating Type
Manual

Noise Level
Silent/None

Dimension (L*W*H)
Ampoule 10 x 60 mm (approx.)

Accuracy
99%

Set Contains
1 ampoule/indicator

Power
Not required (incubation requires incubator)

Adhesive Type
None

Wall Mounted
No

Feature
Visual color change, reliable microbial detection

Biological Indicator for Steam Trade Information

Minimum Order Quantity
100 Vials Pieces

Payment Terms
Letter of Credit (L/C), Cash in Advance (CID), Cheque, Cash Advance (CA)

Supply Ability
100 Pieces Per Week

Delivery Time
7 Days

Sample Available
Yes

Sample Policy
Sample costs shipping and taxes has to be paid by the buyer

Main Export Market(s)
Asia

Main Domestic Market
All India

Certifications
FDA & ISO Certified

About Biological Indicator for Steam

Biological Indicator for Steam is often used for routine monitoring, qualification and load monitoring of a steam sterilizer. It is designed to demonstrate whether the conditions during a steam (autoclave) cycle were adequate to achieve a defined level of microbial inactivation. Biological Indicator for Steam can be availed from us in bulk on time.

Technical Specifications

Brand	SPS Medical & Sterintech
Usage/Application	Monitoring of Sterilization Process
Usages	Hospital, Pharma, Clinic & Laboratory

Steam Sterilization Monitoring

This indicator leverages a robust biological method for steam sterilization process validation, providing critical assurance in hospital, laboratory, and pharmaceutical settings. Its sensitive readout, based on microorganism viability, ensures that only successful cycles pass, offering a clear and simple result with color change technology.

Reliable Visual Readout

Featuring a clear tube and visual media, monitoring is effortlesspurple indicates sterilization failure, yellow signals success. With an accuracy of 99% and compliance with ISO and CE standards, users benefit from dependable microbial detection, enhancing process safety and reducing risk.

Convenient Use and Storage

The portable, single-use ampoule is simple to activate post-sterilization and requires only an incubator at the specified temperature. Store between 2C25C in dry conditions, protected from humidity above 70% RH. Each indicator is individually packed to support traceability and ease of handling.

FAQs of Biological Indicator for Steam:

Q: How do I use the Biological Indicator for Steam sterilization monitoring?

A: After running your steam sterilization cycle at 121C or 134C, activate the ampoule according to the instructions for use (IFU). Incubate it at 55C60C using a suitable incubator and observe for a color change from purple to yellow, which indicates whether viable spores are present.

Q: What is the readout method for this indicator and how reliable is it?

A: The indicator provides a visual color changepurple for non-sterilized, yellow for sterilizedoffering clear and immediate feedback. It achieves an accuracy rating of 99%, supported by ISO 11138 certification and CE marking.

Q: When should I check the results, and how long does incubation take?

A: Results should be checked after the recommended incubation period stated in the instructions for use, typically 24-48 hours. The ampoule must remain at 55C60C throughout incubation for an accurate determination.

Q: Where should these indicators be stored for optimal shelf life?

A: Store the indicators in a dry area between 2C25C with humidity below 70% RH. Proper storage ensures up to 12 months of shelf life from the manufacturing date.

Q: What are the benefits of using these indicators over chemical integrators?

A: Biological indicators directly measure sterilization efficacy by detecting viable spores, providing a higher level of validation than chemical integrators, which monitor physical parameters only. This increases safety and regulatory compliance.

Q: Are these ampoules compatible with all steam sterilizers?

A: Yes, they are suitable for use with steam sterilizers operating at 121C and 134C, making them versatile for hospital, laboratory, and pharmaceutical sterilization processes.

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