#CleanroomMonitoring

[ajtechnovalue]

Role of Cleanroom Monitoring in Pharma

Maintaining a controlled setting within specific boundaries for cleanliness, temperature, pressure, and humidity is known as cleanroom monitoring.

Cleanroom monitoring plays a vital role in upholding product quality and integrity, averting contamination, and ensuring adherence to regulations. Regularly tracking cleanroom conditions like air quality, temperature, humidity, and pressure is crucial to ensure they consistently stay within the accepted limits.

The pharmaceutical industry involves the discovery, development, manufacturing, and marketing of medications used to treat or prevent illnesses.

Cleanroom Monitoring within Pharmaceutical Industries

Cleanroom monitoring is vital for guaranteeing the safety, effectiveness, and quality of produced goods by preventing any form of contamination. In the pharmaceutical sector, cleanroom monitoring is critical for maintaining a contaminant-free manufacturing area within pre-defined regulatory guidelines. To preserve both product quality and patient well-being, it necessitates constant tracking of key parameters such as temperature, humidity, pressure differences, airborne particles, and microbial levels. Cleanroom monitoring aids in GMP and regulatory compliance, helps in preventing contamination, and assures the dependable production of safe, top-tier pharmaceutical products by promptly identifying any possible deviations.

Forms of Cleanroom Monitoring in Pharma Industries

Different types of cleanroom monitoring are applied within the pharmaceutical industry.

Continuous Monitoring

This involves real-time systems for monitoring cleanrooms connected to data loggers or building management systems (BMS), particularly in high-risk zones (Grade A/B).

Periodic Monitoring

This supports the data from continuous monitoring with routine sampling and verification checks, essential for identifying microbial contamination.

Validation and Qualification

Installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) are all part of this stage of cleanroom validation.

Devices and Tools for Cleanroom Monitoring

Some of the cleanroom monitoring instruments utilized by the pharmaceutical industry include:

Portable Particle Counter

Portable Microbial Sampler/Real-Time Viable Sampler

Airborne particle counters

You can find further information and similar products at www.technovalue.in.

Conclusion

Efficient cleanroom monitoring within the pharmaceutical industry is critical for ensuring product quality, compliance with regulations, and patient safety. Advancements in real-time monitoring systems now enable the identification of even minor deviations before they evolve into major problems.

By investing in strong pharmaceutical cleanroom monitoring solutions and adhering to GMP cleanroom standards, companies can maintain high-level quality assurance and ensure compliance with international regulations.

[vegabazaar]

Rotronic HP32 Hygropalm Handheld Hygrometer Buy : https://vegabazaar.com/product/top-hydropalm-meter-rotronic-hp32-hygropalm-handheld-hygrometer

[nikkhil989]

AeroTrak-Plus Portable Particle Counter A100 Series AeroTrak™+ Portable Airborne Particle Counters (APCs) are ideal for all industries for cleanroom certification, monitoring and specialized tasks including gas testing and filter scanning. Engineered for you, they provide the newest features you've been asking for in a portable particle counter: Data integrity (including Annex 1) Communication options Intuitive GUI — requires no manuals to operate, significantly reducing the chance for user error and simplifying monitoring for environmental contamination These features lead to a better user experience and easy compliance. Built in standards for configuration and reports to meet the standards driving the market include: ISO 14644-1:2015 - Cleanrooms and associated controlled environments ISO 21501-4:2018 - Calibration standards EU GMP Annex 1 (2008 and 2022) – Good Manufacturing Practice: Manufacture of Sterile Medical Products China GMP Standalone or as part of an easy to use complete monitoring system, AeroTrak™+ Portable Particle Counter A100 Series meets your needs

Applications:

Pharmaceutical manufacturing — routine monitoring and investigations

Semiconductor and/or electronics manufacturing — investigations and size characterization

Cleanroom certification — classification, filter testing, and recovery rate

Features and Benefits :

One instrument does it all- classify, monitor, filter scan, gas testing and root-cause analysis

Highly visible status conditions - LED light bar viewable 20 meters / 360°

Access user controls for GMP compliance

Sample the correct volume of gas with built in gas correction factors

Automated ISO 14644-1 and GMP (EU GMP and China GMP) reporting and instrument workflow with included TrakPro™ Lite Secure Software

Filter test and investigate mode (both audible and visual)

ISO 21501-4 calibration compliance

WiFi® enabled connectivity

Industry best 5 year laser warranty

Fit for purpose - easy to clean, stainless steel housing

Simplify integration into third party systems with 4-20 mA analog particle data output and environmental sensor input options

Multiple instrument reporting supported by latest TrakPro™ Lite Secure Software

visit www.technovalue.in for more

[technovale]

Emtek V100 CONTROLLER

The Versatile 100 (V100), an addition to the EMTEK line in 2010 offers a high level of versatility in microbial air sampling capabilities.

Operates R2S, RAS, and RCG Samplers

Operates 1 to 4 RAS, or 1 or 2 R2S or RCG Confined Space air samplers

Color LCD with Touch Screen Interface

IR Remote Control (Start/Stop/Rest, Pause/Resume)

On Screen Test Plate Sample Tracking

Mass Flow Controlled Sample Rates @ 28.3, 50 & 100 LPM

0-120 Minutes of Active Monitoring per Test Period

Custom Test Delay, Hold and Run Programmability

Test Period Pause/Resume Capability

On Board Label Printer Outputs Key Sample Parameters

Sample Memory Buffer >500

Ethernet Connectivity for Data Downloads

USB Connectivity for Calibration and Maintenance

Maintains >300 Sample Location Entries

Mass Flow and Sampling Set Up Error Alarms

Easily sanitizable and Kydex TM w/Microban TM / 316SS Instrument Case

Easily portable at only 12 pounds

Extendable/Retractable handle for easy transport

0.2 micron Filtered HEPA Exhaust

Operates at 115 VAC @ 60Hz and 220 VAC @ 50Hz

Only 10” L X 8” W X 7” H

Power Cable/Vacuum Line Assembly, Standard 12’

Visit www.technovale.in for more info.

[labequipment]

Handheld Airborne Particle Counter

Labmate Handheld Airborne Particle Counter is ideal for clean room applications, featuring multi-channel capabilities to count particles of 0.3 µm, 0.5 µm, 1.0 µm, 2.0 µm, 3.0 µm, and 5.0 µm. Its audible alarm system with user-selectable limits ensures optimal air quality. Portable and lightweight, it includes standard data communication software for easy data transfer and analysis.

[antistaticworkwear]

CLEANROOM ESD !!! 0812-8571-9339, Produsen Baju Kerja Cleanroom Antistatic, CIBODAS Kota Tangerang Banten

SERAGAM MODEL JUMPSUIT !!! CALL 0812-8571-9339, Seragam Kerja Ruang Kerja Cleanroom Bahan Antistatic.

CHAT ME :  https://wa.me/6281285719339, Clean Room Garments, Cleanroom ESD Mats, ESD Cleanroom Products, Cleanroom ESD Smocks, Baju Seragam Cleanroom, Jual Baju Searagm Cleanroom, Baju Seragam Antistatik, Baju Bahan Antistatic, Antistatic Bag, Cleanroom ESD Coverall, Sticky Mat Blue, Smock Antistatic, Jumpsuit Antistatic, Coverall Antistatic, Wearpack Antistatic, Pakaian Kerja Ruang Cleanroom.

Jumpsuit Antistatic Baju Seragam Kerja Antistatic merupakan pakaian yang dirancang khusus untuk perusahaan Elektronik, Outomotive, Farmasi, dsb. Pakain atau Baju Antistatik dibuat khusus untuk mengurangi aliran listrik yang ada pada tubuh manusia , sehingga bisa menekan angka kerusakan pada produk atau komponen yang dihasilkan ( komponen elektronik , dsb ) aman dipakai, safety First.

Jenis Pakaian Seragam Kerja Antistatic berfariasi dan nyaman dipergunakan, mudah untuk dibersihkan atau dicuci, pakaian berteknologi tinggi untuk industri farmasi, industri mikro-elektronik, Outomotive , Optik, Makanan & dll.

Kami menyediakan pakaian ESD Antistatic dengan beberapa type dan jenis yang dapat disesuaikan dengan tempat kerja , tediri dari: Coverall / Jumpsuit , Smock / Lab Coat / Jaslab , Seragam Kerja / Setelan Baju + Celana , Sarung Sepatu , Cover Boot , Sarung tangan / Glove , Hod / Balaclavia , Sticky Mat , Sticky Roller , Handle Sticky Roller.

Produsen Baju Antistatic, Distributor Baju Antistatic Jumpsuit Warna Biru size XXL, Distributor utama Baju Antistatic Jumpsuit Warna Biru size XXL, Jual Baju Antistatic Jumpsuit Warna Biru size XXL, Pemasok Baju Antistatic Jumpsuit Warna Biru size XXL, Baju Antistatic Jumpsuit Warna Biru size XXL Murah.

Tersedia pilihan warna : Biru , Kuning , Merah , Putih , Pink , Blue Navy , Brown , Hijau.

SPESIFIKASI PRODUK :

Material kain ESD Antistatic (Bersertifikat)

Terdapat Elastik pada pergelangan Tangan dan Kaki

Kancing menggunakan Ritsleting yang di cover

Tersedia beberapa Model/Type Seragam Tersedia pilihan warna dan ukuran

HUBUNGI KAMI :

EVEREST GLOBAL INDONESIA | MPJ SUPPLIER

JL. Nakula Raya No. C158, Jakasetia, Bekasi SelatanKota Bekasi, Jawa Barat 17147

Telp / Whatsapp  :   https://wa.me/6281285719339

Email   : mpj.jaya@gmail.com

KUNJUNGI :

http://www.seragamcleanroom.com/

https://www.jacketcoldstorage.com/

https://bajuapdhazmat.com/

[atlantictechsys-blog]

Learn about updated ISO  regulations and effective cleanroom management with these tips.

[ajtechnovalue]

AeroTrak Remote Particle Counter with Integrated Pump 6510 & 6510-VHP

AeroTrak® Remote Particle Counters with Integrated Pump are independent monitoring systems condensed into an easy-to-clean 316L stainless steel enclosure. The integrated clean pump eliminates the need for an external vacuum source. Four standard analog inputs help to reduce installation and integration costs. Vaporized Hydrogen Peroxide (VHP) resistant remote particle counter model available. Models 6510 and 6510-VHP offer 4 size channels, 0.5, 0.7, 1.0, 5.0 μm at 1 CFM (28.3 L/min) sample flow rate. The sample inlet capping auto-detect automatically stops the blower and prevents accidental damage.

Applications :

GMP Controlled Areas

Isolators

Restricted Access Barrier Systems (RABS)

Cleanrooms

Hospital Pharmacies

Laboratories

Industrial

Aerospace

Compounding Pharmacies

Features and Benefits:

Easy to Install and Maintain

Eliminates the need for centralized vacuum system

Internal blower has no carbon vanes and low heat gain

Hot-swap optical sensor and pump slide out as a single assembly for fast and easy maintenance, no tools required

Sample inlet capping auto-detect automatically stops the blower and prevents accidental damage

Standard four 4-20 mA analog inputs reduce environmental sensor integration and installation costs

Easy-to-clean passivated 316L stainless steel enclosure, sample probe and cap, which are resistant to cleaning solutions

Ethernet (TCP/IP), serial Modbus RTU, and 4-20 mA analog data outputs enable seamless integration into most software, including TSI’s FMS software. 

Meets Current GMP Guidelines and International Standards :

1 CFM (28.3 L/min) flow rate, up to four channels of particle data including 0.5 μm and  5 μm per EU and US FDA Aseptic Processing Guidelines

ISO 21501-4 compliant calibration delivers consistent instrument counting and sizing performance

FMS 5 monitoring software integration enables 21 CFR Part 11-compliant data collection.

[ajtechnovalue]

P-Trak Ultrafine Particle Counter 8525

This portable instrument detects and counts ultrafine particles (smaller than 1 micrometer) that often accompany or signal the presence of a pollutant that is the root cause of complaints. Ultrafine particles are defined as having a diameter less than 0.1 μm (or 100 nm). Engineered nanoparticles (nanomaterials) are a subset of ultrafine particles with dimensions from 1 to 100 nm. Nanomaterials are produced and used for industrial and high-tech applications, while ultrafine particles are the byproducts of combustion and other chemical reactions. Unfortunately, the occupational health risks associated with manufacturing and using nanomaterials are not clearly understood. As a result, a need has arisen to assess workplace conditions. Using TSI’s proven technology, the P-Trak gives direct, real-time measurement of workplace ultrafine particulate levels. The P-Trak Ultrafine Particle Counter locates obvious pollutant sources such as boilers, furnaces, and vehicles, and it also detects the not-so-obvious sources such as photocopy machines and printers. Use this instrument to detect the migration of toxic exhaust gases, malfunctioning office equipment, pinhole gasket leaks in boilers and a wide variety of other problems.

Applications

Check office equipment

Cleanroom containment checks

Filter checks

Check fume hoods

Check safety cabinets

Vehicle emission migration

Combustion leaks

Control smoking areas

Included Items

Telescoping sample probe

Sample tube

Inlet screen

Spare wicks (2)

Battery holder

Alkaline batteries (6 AA)

Alcohol fill capsule with storage cap

Alcohol cartridge

30ml bottle reagent grade isopropyl alcohol (16)

Zero filter (2)

Carrying case

TrakPro software

Computer cable

Operation and service manual

Calibration certificate

Two-year warranty

Features and benefits

Real-time ultrafine particle counter

Solves tough IAQ problems

Easy to use

Data log information

[ajtechnovalue]

AeroTrak Handheld Particle Counter 9306

The TSI AeroTrak™ Handheld Particle Counter Model 9306 offers the most features and flexibility for customers interested in versatile handheld particle contamination monitoring. The Model 9306 features an ergonomic handle with thumb controls, for easy one-hand operation. The 3.6-inch (9.1-cm) color touch screen interface makes it easy to configure and operate. The Model 9306 can generate Pass/Fail reports for ISO 14644-1, EU GMP Annex 1, and FS209E. Particle count data can be conveniently viewed on screen, downloaded using TrakPro™ Lite Secure Software, or printed directly to an optional external printer. Multiple AeroTrak 9306 Particle Counter configurations can be conveniently stored and uploaded as needed using the TrakPro Lite Secure data download and reporting software supplied as standard. The Model 9306 complies with all the stringent requirements set forth in ISO 21501-4. These particle counters are calibrated with NIST traceable PSL spheres using TSI’s world-class classifier and condensation particle counters, the recognized standard for particle measurements. This particle counter can be placed in Data Integrity Mode for enhanced data integrity. Used in conjunction with TSI TrakPro™ Lite Secure Software, Data Integrity Mode is designed per the ALCOA+ principles to meet the demanding regulatory requirements of GMP users. Learn more >

[ajtechnovalue]

AeroTrak Handheld Particle Counter 9303

The TSI AeroTrak® Handheld Particle Counter Model 9303 offers the most features and flexibility for customers interested in a low cost and versatile handheld particle counter. The Model 9303 features a sturdy yet lightweight high-impact injection-molded plastic design for easy handling. The instrument is easy to configure using an intuitive keypad. The internal memory can store up to 1,500 sample records of particle count data which can be conveniently viewed on screen or downloaded using a USB port to TSI’s TrakPro™ Lite Secure Software. The instrument reports up to three particle sizes simultaneously. The middle channel is user selectable for either 0.5, 1.0, 2.0, or 2.5 μm.The Model 9303 complies with all the stringent requirements set forth in ISO 21501-4. It is calibrated with NIST traceable PSL spheres using TSI’s world-class Classifier and Condensation Particle Counters, the recognized standard for particle measurements.

Download Software:

To download applicable software and/or firmware, please use the Software/Firmware Wizard.

Features and Benefits:

0.3 to 25 μm size range

0.1 CFM (2.83 L/min) flow rate

Up to three channels of simultaneous data

ISO 21501-4 compliant

USB serial output

Compatible with TrakPro Lite Secure 

[nikkhil989]

What is a PARTICLE COUNTER Understanding Its Working, Types, and Applications

Industries such as pharmaceuticals, cleanrooms, HVAC systems, healthcare, and environmental monitoring heavily rely on airborne particle counters and liquid particle counters to ensure quality control and regulatory compliance. This blog will explore how a particle counter works, the different types of particle counters, and their key applications in different industries.

What is a Particle Counter?

A particle counter is a device used to measure the size and number of particles in air, liquid, or surfaces. These instruments help monitor indoor air quality (IAQ), detect contaminants in pharmaceutical manufacturing, and ensure compliance with ISO standards for cleanroom classifications

Particle counters are crucial in industries where even microscopic contamination can cause product defects, health hazards, or regulatory issues.

Applications of Particle Counters  

1. Cleanroom Monitoring

Pharmaceutical and semiconductor industries rely on ISO-certified particle counters to maintain contamination-free environments.

2. Indoor Air Quality (IAQ) Monitoring

HVAC systems, hospitals, and offices use particle counters to detect pollutants like dust, pollen, bacteria, and mold spores.

3. Environmental Monitoring

Air quality monitoring systems help detect pollution sources in industrial zones, urban areas, and construction sites.

4. Pharmaceutical & Food Safety

Liquid particle counters ensure that injections, vaccines, and beverage production meet stringent purity standards.

5. Aerospace & Semiconductor Manufacturing

Highly sensitive particle counters help maintain ultra-clean environments essential for chip fabrication and satellite manufacturing.

Choosing the Right Particle Counter

When selecting a particle counter, consider factors like:

Size range detection – Ensure it meets your required particle size measurement.

Flow rate and sensitivity – Important for real-time air quality monitoring.

Compliance with ISO and GMP standards – Necessary for regulated industries.

Data logging and connectivity – Integration with IoT and remote monitoring capabilities

[technovale]

Emtek P100 Portable Microbial Air Sampler

With two controlled air sampling rates, the Emtek P100 Portable Microbial Air Sampler can be used to either continuously monitor the environment, or take quick “grab” samples as needed, allowing you to obtain microbial samples with a minimum of interference in your cleanroom.

Features :

Lightweight and portable

Controlled sample rates of 28.3 (1 CFM) and 100 LPM

Long battery life

Operation via touch screen interface or optional PC based software

Creation and storage of unique sampling plans

Delay/Test/Hold functionality

CFR Part 11 regulatory compliant data control

500 sample records storage

Output to optional label printer, USB, or optional PC based software

Visit www.technovlaue.in for more info.

#MicrobialAirSampler

#CleanroomMonitoring

#AirQualityTesting

#EnvironmentalMonitoring

#EmtekP100

#CFRAuditReady

#PortableAirSampler

#AirSamplingTechnology

#PharmaCleanroom

#GMPCompliance

#AirQualityControl

#CFRPart11

#TouchScreenSampler

#LaboratoryEquipment

#BiotechTools

#CleanroomSolutions

#AirSampler

#MicrobialMonitoring

#EnvironmentalSafety

#TechnovalueIndia

[technovale]

TVSPL High Pressure Diffuser

For Total Air Particulate of Compressed Air/Gas we can use it in conjunction with a 1CFM, 28.3LPM, 50LPM, 75LPM, or 100 LPM Optical Particle Counters of all makes.

TECHNICAL SPECIFICATIONS

Material of Construction: SS 316 (Stainless Steel)

Output Flow/Use: 1 CFM, 28.3 LPM, 50 LPM, 75 LPM, or 100 LPM

Requirements Suitable For: All Makes Optical/Laser Particle Counters

Inlet Pressure Required: 25 to 125 PSI (approx for HPD)

HPD Dimensions (Approx): 140mm x 32mm QD

HPD for 1 CFM/28.3 LPM OPC: Model No. TVS HPD SS6 001 (TVSPL High Pressure Diffuser)

HPD for 50 LPM OPC: Model No. TVS HPD SS6 050

HPD for 75 LPM/100 LPM OPC: Model No. TVS HPD SS6 100

HPD for 28.3/50/100 LPM OPC: Model No. TVS HPD SS6 002*

Visit www.twchnovale.in for more info.