How often should the device be calibrated?

Calibration is recommended once a year to maintain accuracy.

Reliable Cleanroom Air Sampler Ksm-S, 21 CFR Part 11 Compliance

Name: Reliable Cleanroom Air Sampler Ksm-S, 21 CFR Part 11 Compliance
Brand: Jinan Kosemo Precision Instruments Co., Ltd.
SKU: 2310436195

Shandong, ChinaJinan Kosemo Precision Instruments Co., Ltd.

US$2,500.00

1-19 Pieces

US$2,150.00

20+ Pieces

Product profile

Product Model

Ksm-S Microbial Air Sampler

Sampling Principle

Based on Andersen Impaction Principle

Nominal Flow Rate

100L/Min ±5%

Model NO.

KSM-S

Sampling Volume

1-10000L

Sampling Mode

Support Sqs Segmented Sampling Function

Display Configuration

Equipped with 6-Inch HD Touch Screen

Storage

20000 Sets of Sample Data

Power Supply

Input 100-240VAC,50/60Hz,2.5A

Battery

Lithium Battery, Continuous Operation Over 7 Hours

Material

Anodized Aluminum Alloy

Transport Package

Standard Export Packing

Specification

120×202×48(mm)

Trademark

Origin

China

HS Code

9027809900

Key features

FDA 21 CFR Part 11 Compliance: Ensures data integrity and meets strict regulatory requirements for pharmaceutical and medical industries.

Andersen Impaction Principle: Utilizes high-performance vacuum pump and porous head for accurate microbial capture on agar plates.

Remote Sampling Capability: Powerful fan enables split-type remote sampling for flexible deployment in aseptic environments.

Large Data Storage: Stores up to 20,000 sets of sample data and 20,000 sets of audit trail operation logs.

Long Battery Life: Equipped with lithium battery providing continuous operation for over 7 hours.

User Management System: Supports three user groups with unlimited users, audit trails, and comprehensive data recording.

Multi-Language Support: Interface available in both Chinese and English for global usability.

Company profile

Jinan Kosemo Precision Instruments Co., Ltd.Shandong, China

Business Type: Trading CompanyExport Year: 2025-12-01Nearest Port: Qingdao, RizhaoAverage Response Time: ≤6.26hTerms of Payment: LC, T/T, D/P, etc.International Commercial Terms(Incoterms): FOB, EXW, CFR, CIF, DAT, FAS, DDP, DAP, CIP, CPT, FCA

About Our Factory & Business Background

AddressRoom 1711, Building a, Lujin Center, No. 12 Beiyuan Street, Quanfu Subdistrict, Licheng District, Jinan City, Shandong Province, Jinan, Shandong, China

Average Lead TimePeak Season Lead Time: within 15 workdays Off Season Lead Time: within 15 workdays

Our Production Capability & Technical Expertise

Main ProductsAir Tightness Detector, Mass Flow Meter, Trace Oxygen Analyzer, Hydrogen Leak Detector, Sealing Test Bench, Aerosol Generator, Sealing Test Instrument, Microbial Air Sampler, Portable Gas Analyzer, Gas Leakage Tester

Our Industry Experience & Global Business Record

Main MarketsNorth America, South America, Eastern Europe, Southeast Asia, Africa, Oceania, Mid East, Eastern Asia, Western Europe

Product Q&A

Q:What is the sampling principle of this device?

The KSM-S Microbial Air Sampler is designed based on the Andersen impaction principle, drawing air through a vacuum pump to impact microorganisms onto agar-coated petri dishes.

Q:Does this product comply with FDA regulations?

Yes, it is fully compliant with FDA 21 CFR Part 11 data integrity requirements.

Q:How long does the battery last on a single charge?

The built-in lithium battery supports continuous operation for over 7 hours.

Q:What materials are used for the housing?

The housing is made of anodized aluminum alloy with a smooth, dead-angle-free surface for easy cleaning.

Q:What communication interfaces are supported?

The device supports TCP/IP, USB, and WIFI for data transmission and remote control.