Environmental Monitoring Systems for critical applications

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Environmental Monitoring Systems for critical applications Cleanrooms A division of Laftech Pharmaceutical Innovative Technology Solutions that Count!

for local Industry. Laboratories At LAFtech we specialise in for your laboratory, cleanroom, hospital or research facility.

We monitor the equipment we supply and the rooms where they are operating to meet strict cgmp and regulatory requirements.

alarms for out of specification trends, and sending immediate notification by SMS, email or pager.

1 Environmental Monitoring Systems for critical applications Cleanrooms A division of Laftech Pharmaceutical Innovative Technology Solutions that Count! As the authorised Australian and New Zealand agents for Lighthouse Worldwide Solutions, we provide a complete line of environmental monitoring instruments, systems and contamination control equipment for local Industry. Laboratories At LAFtech we specialise in for your laboratory, cleanroom, hospital or research facility. EMStech is a division of LAFtech that is dedicated to providing bespoke Environmental. EMStech supplies portable and automated environmental monitoring systems. We monitor the equipment we supply and the rooms where they are operating to meet strict cgmp and regulatory requirements. Hospital & Healthcare EMStech offers a total solution providing clients with a monitoring system which is compliant and easy to use collecting all critical data, storing it securely and monitoring alarms for out of specification trends, and sending immediate notification by SMS, or pager. From concept to design, commissioning, installation and validation, the environmental monitoring systems, services and support EMStech provides will help ensure your facility runs smoothly and without complication. Solutions Industry / Manufacturing Airborne Particle Counters Liquid Particle Counters Microbial Air Samplers Environmental Monitoring Systems Temperature, Humidity and Pressure Local calibration and service facility. Design & Installation cgmp Regulatory compliant monitoring systems Full turnkey solution following GAMP standards Easy to use software and easily configurable Assessable data and trending real time information Automated compliance reports generated. 1

Cleanroom Automotive and Paint Spray Semiconductor and Flat Panel TV Aerospace / Defence Sterile Packaging Controlled Environment Equipment Cleanroom Certification.

cleanroom standard. Our monitoring software can easily integrate many different types of sensors to achieve a more complete monitoring system.

2 Cleanroom Automotive and Paint Spray Semiconductor and Flat Panel TV Aerospace / Defence Sterile Packaging Controlled Environment Equipment Cleanroom Certification. Cleanroom monitoring can be accomplished in a number of ways by using discrete portable particle counters, remote point of use particle counters and/or a manifold system to meet the ISO cleanroom standard. Our monitoring software can easily integrate many different types of sensors to achieve a more complete monitoring system. Real Time EMS providing you with Quality Assurance and Quality Control SMS and Paging Internet Client Internet Alerts Data Collection & Control Differential Pressure Air Velocity Electrostatic Charge Detector Manifold Particle Counter Temperature Relative Humidity Fan Ionizer KEY BENEFITS Automated Monitoring System Facilitates Cleanroom Certification Configurable Alert and Alarm Settings Immediate Notifications to Staff Continuous Sampling and Monitoring Secure Data Capture and Storage Reduced Labour Cost. Room (Overhead) Ionization System Pharmaceutical Particle Counting Microbiological Monitoring Temperature Relative Humidity Pressure Differential. The production of sterile pharmaceuticals is carried out in various classes of cleanrooms. The most critical operation is during aseptic preparation and filling. Measurements must be monitored during production of these drugs, and data collection is carried out in an automated fashion. Our monitoring systems enable real time monitoring and data collection to meet critical applications. Real Time Data Trending & Alarm Notifications allowing more decisive decision making Viable Particle Sampling Impactor Remote Particle Counters Using External Vacuum Source Temperature Relative Humidity Differential Pressure Air Velocity Red Yellow Green Buzzer View Clients Primary Data Collection & Control Pump Control Redundant Data Collection & Control Dedicated or Corporate Network Duplex Vacuum Pump System with Fail-Over and Control Network Hub 2

Hospital & Healthcare Pharmacy Dispensing Cleanrooms Sterile Compounding Cytotoxic Cleanrooms Radio-pharmaceutical Facilities Cell & Tissue Cleanrooms Hospital Laboratory

Our Environmental Monitoring Systems are flexible and can monitor several facilities simultaneously on one complete system.

Hospital Operating Rooms The Operating Room monitoring system is a compact monitoring system with full network support.

The Operating Room monitoring system is developed and maintained by GAMP5 regulations and complies with FDA s 21 CFR part 11.

The presentation of the readings is provided by a simple interface.

the values behind his or her PC in real time.

Innovative & Integrated Solutions Surgery Operating Theatres Temperature of Supplied Air Return Temperature Particle Counting in Plenum Air Velocity in Plenum Room Particle

in the Operating Room Doorway Opening Counts Laboratory Microbiological Monitoring Temperature Relative Humidity CO2 Gas Incubators Cryogenic Storage Cell & Tissue Storage TOC

3 Hospital & Healthcare Pharmacy Dispensing Cleanrooms Sterile Compounding Cytotoxic Cleanrooms Radio-pharmaceutical Facilities Cell & Tissue Cleanrooms Hospital Laboratory Equipment. Monitoring of hospitals can be implemented across different departments. Our Environmental Monitoring Systems are flexible and can monitor several facilities simultaneously on one complete system. Or each system can be dedicated to each department for more flexibility. Hospital Operating Rooms The Operating Room monitoring system is a compact monitoring system with full network support. It supports a wide range of instrumentation and can be customised to control and monitor special equipment. The Operating Room monitoring system is developed and maintained by GAMP5 regulations and complies with FDA s 21 CFR part 11. Lighthouse Operating Room monitoring system gives you an insight into the process of your Operating Room facility. The presentation of the readings is provided by a simple interface. This client application provides various network users, including the TD chief, Chief Hospital hygienist and the Operating Room Manager, with the ability to manage and report the values behind his or her PC in real time. KEY FEATURES Local Alarm Option Web-based Users User Friendly Link to GBS SQL Database Software under GMP 5 Years Data Storage Audit Trails Validation Options MONITORING Innovative & Integrated Solutions Surgery Operating Theatres Temperature of Supplied Air Return Temperature Particle Counting in Plenum Air Velocity in Plenum Room Particle Counting Microbiological Sampling Heads for Equipment on the Table Particle Counting in the Return Channel Microbiological Sampling Head in Return Channel Pressure Differences in the Operating Room Doorway Opening Counts Laboratory Microbiological Monitoring Temperature Relative Humidity CO2 Gas Incubators Cryogenic Storage Cell & Tissue Storage TOC & O2 Gas. Critical Equipment Monitoring APPLICATIONS KEY BENEFITS In today s laboratory environment data collection has become a top priority. Cells, tissue, embryos, cultures and other critical materials need monitoring where they are stored. If a Cryogenic Freezer fails in operation then the embryo can be lost forever. LMS Software from Lighthouse Worldwide Solutions has been designed to cater for all types of laboratories. It enables a laboratory to monitor all of the critical equipment. LMS can perform alarming only or do continuous monitoring and data collection of vital equipment parameters. We also offer wireless monitoring systems. Fridges Freezers Incubators Bio Cabinets Centrifuge Isolators Ovens Autoclaves Automated Monitoring System No more chart recordings Secure Data Capture and Storage Out of Hours Alarming SMS/ notifications Door open/closed Alarms Equipment Failure Alarms 3

Environmental Monitoring Products Handheld, Portable and Remote Particle Counters Extreme Life Laser Diode Technology Greater than

EMStech can design, install and maintain your contamination monitoring system.

REMOTE PARTICLE COUNTER Incorporating the latest in laser optical particle counting technology, Lighthouse designed the REMOTE 5104

3 L/min), the REMOTE 5104 provides real-time continuous data collection at a cost effective price per point and is easily mountable

PORTABLE PARTICLE COUNTER SOLAIR Portable Particle Counters come in a stainless steel enclosure.

With fast, reliable sampling of 1m³ of air in only ten minutes, the SOLAIR 3350 and SOLAIR 5350 particle counters offer faster

3µm portable designed for continuous use.

MTTF. LIQUID PARTICLE COUNTER HANDHELD PARTICLE COUNTER The ergonomically designed and lightweight Lighthouse HANDHELD 2016, 3016

5µm sensitivities and are the most advanced handheld particle counters on the market with colour touch screen and advanced report

HANDHELD AIR SAMPLER The New Lighthouse MAS-100 NT Serves to measure the microorganisms in cleanrooms and sterile environments

The use of standard 90-100mm Petri dishes, the integrated mass-flow sensor and the handiness of this air sampler are unique on the

4 Environmental Monitoring Products Handheld, Portable and Remote Particle Counters Extreme Life Laser Diode Technology Greater than 25 Years Laser Diode Life Colour Touch Screen Detailed Reporting Functions Self Diagnostics of Sensors ISO Calibrations. EMStech can design, install and maintain your contamination monitoring system. We offer calibration, service, repair, contamination control training and consultation services. REMOTE PARTICLE COUNTER Incorporating the latest in laser optical particle counting technology, Lighthouse designed the REMOTE 5104 for continuous trouble-free operation. With a sensitivity of 0.5µm, at a flow rate of 1.0 CFM (28.3 L/min), the REMOTE 5104 provides real-time continuous data collection at a cost effective price per point and is easily mountable in any location. More model options available with particle sizes and flow rates including models with a built in vacuum source. PORTABLE PARTICLE COUNTER SOLAIR Portable Particle Counters come in a stainless steel enclosure. SOLAIR s model range can measure different particle sizes and flow rates. With fast, reliable sampling of 1m³ of air in only ten minutes, the SOLAIR 3350 and SOLAIR 5350 particle counters offer faster cleanroom certification required by ISO SOLAIR 3350 is the industry s only 100 L/min 0.3µm portable designed for continuous use. SOLAIRs incorporate our Extreme Life Laser Diode Technology sensor to produce the industry s longest laser diode life of 25+ years MTTF. LIQUID PARTICLE COUNTER HANDHELD PARTICLE COUNTER The ergonomically designed and lightweight Lighthouse HANDHELD 2016, 3016 and 5016 particle counters feature 0.2, 0.3 and 0.5µm sensitivities and are the most advanced handheld particle counters on the market with colour touch screen and advanced report generation. Includes RHT probe and download software. HANDHELD AIR SAMPLER The New Lighthouse MAS-100 NT Serves to measure the microorganisms in cleanrooms and sterile environments especially in pharmaceutical companies and hygienically highly sensible areas. The use of standard mm Petri dishes, the integrated mass-flow sensor and the handiness of this air sampler are unique on the market. A PC-interface permits the program to read data from the air sampler for further information on air sampler selection follow the ISO guideline. The Lighthouse LS-20 Liquid Sampler has an integrated syringe sampler and optical particle counting system. It s easy-to-use Windows based software interface is designed to meet the international regulatory EP and JP, as well as USP 788, requirements. Following a quality standard of reliability and dependability, Lighthouse Worldwide Solutions developed the LS-20 Liquid Sampler using the latest in laser optical particle counter technology. Lighthouse offers many more models of liquid particle counters to test for online applications including online WFI loops. 4

Pharmaceutical COMPRESSED GAS PARTICLE COUNTING The High Pressure Diffuser was designed for use with SOLAIR Particle Counters in applications where the sample is under

Standard applications include sampling of Air, Nitrogen and other inert gasses introduced to cleanrooms, this technology allows the user to follow ISO 8573 guidelines for

SCANAIR PRO SYSTEM The ScanAir Pro System is the only easy and lightweight method for testing PTFE HEPA filters using alternative polystyrene latex spheres as per ISO-14644-3

Incorporating an ergonomic lightweight scanning probe with touch screen user interface, the Scan Air Pro System also includes a SOLAIR portable particle counter and a

The ScanAir Pro performs upstream and downstream measurement with an automatic upstream challenge calculation based upon sample and displays a percentage leak during

KEY BENEFITS The ability to challenge test filters with a much lower concentration of oil thus reducing oil residue in cleanroom facilities Reduces the over saturation of HEPA

instead of PAO for filter challenge testing at specified particle size Increases resolution by a factor of 10 compared to using DOP and photometer technology Multi-function:

Software The Lighthouse Monitoring System (LMS) software packages provide a single point of configuration and data analysis.

The LMS Pharma monitoring software system collects, displays and analyses data for all phases of pharmaceutical operations.

5 Pharmaceutical COMPRESSED GAS PARTICLE COUNTING The High Pressure Diffuser was designed for use with SOLAIR Particle Counters in applications where the sample is under pressure. It s easy to attach between the gas line and SOLAIR particle counter. Standard applications include sampling of Air, Nitrogen and other inert gasses introduced to cleanrooms, this technology allows the user to follow ISO 8573 guidelines for testing compressed gases. SCANAIR PRO SYSTEM The ScanAir Pro System is the only easy and lightweight method for testing PTFE HEPA filters using alternative polystyrene latex spheres as per ISO standard. Use the ScanAir Pro to scan filter media for leaks and provide a measurement of filter efficiency. Incorporating an ergonomic lightweight scanning probe with touch screen user interface, the Scan Air Pro System also includes a SOLAIR portable particle counter and a configurable dilutor for when concentrations exceed programmed thresholds. The ScanAir Pro performs upstream and downstream measurement with an automatic upstream challenge calculation based upon sample and displays a percentage leak during downstream mode along with alarm indicator. KEY BENEFITS The ability to challenge test filters with a much lower concentration of oil thus reducing oil residue in cleanroom facilities Reduces the over saturation of HEPA filters using DOP aerosols which typically cause false positive results Virtually no coalesce of aerosol, thus no liquid accumulation in fans or duct work Ability to use PSL instead of PAO for filter challenge testing at specified particle size Increases resolution by a factor of 10 compared to using DOP and photometer technology Multi-function: use the same instruments for filter testing, cleanroom classification, cleanroom recovery testing per Annex 1 and testing of pressurised gases (with high pressure diffuser). Software The Lighthouse Monitoring System (LMS) software packages provide a single point of configuration and data analysis. Offering the capability to view graphs, charts, maps, SPC, system status, sensor status, and more. Each can be customised and displayed simultaneously. The LMS Pharma monitoring software system collects, displays and analyses data for all phases of pharmaceutical operations. It provides automated and sophisticated alarm, notification, data viewing, reporting and auditing capabilities compliant with 21 CFR part 11. Designed for high-reliability secure facility monitoring, LMS software integrates robust and comprehensive security with system data redundancy and an intuitive easy-to-use interface. Real time and historical data can be securely viewed and analysed in maps, trendcharts (graphs), data tables, and fully customisable reports, with full alarm notification, acknowledgment and reporting capabilities. The LMS Express 7 family of small monitoring systems is designed to collect and display data from Lighthouse SOLAIR, HANDHELD and REMOTE Particle Counters as well as from the Lighthouse Universal Manifold Controller, Mini Manifold and Mini Multiplexer. This system can offer a more economical solution where there are low numbers of sensors. 5

Solutions Environmental Monitoring Airborne Particle Counters Liquid Particle Counters Microbial Samplers Complete Facility Monitoring Systems - Design, Installation & Validation Controlled

Cabinets - Safety Storage Cabinets - Extraction Arms - Filtration Systems Anaerobic/Hypoxia Workstations Incubators Bio-decontamination Equipment Forensic Equipment General Laboratory Equipment - Lab

6 Solutions Environmental Monitoring Airborne Particle Counters Liquid Particle Counters Microbial Samplers Complete Facility Monitoring Systems - Design, Installation & Validation Controlled Environment Equipment Contamination Control - Biological Safety Cabinets - Laminar Flow Cabinets - Cytotoxic Cabinets - PCR Cabinets - Isolator Technologies Chemical / Powder Safe Handling - Fume Cabinets - Safety Storage Cabinets - Extraction Arms - Filtration Systems Anaerobic/Hypoxia Workstations Incubators Bio-decontamination Equipment Forensic Equipment General Laboratory Equipment - Lab Ovens and Furnaces - Baths and Circulators - Lab Vacuum Equipment - Lab Equipment Chambers - Ultrasonic Bath Cleaners Air Filters Complete Service Capability Mechanical Testing - Cleanrooms - Biological Safety Cabinets - Laminar Flow - Chemical Fume Hoods - Isolation Rooms - Pharmaceutical Isolators - Cytotoxic Cabinets - HEPA Filtered Systems ihp Bio Decontamination HPV Decontamination Accreditation LAFtech is a fully owned and operated Australian company At LAFtech we provide a premium range of quality biological safety equipment, including laminar flow, cytotoxic and compounding safety cabinets, contamination control laboratory equipment including laboratory fridges, freezers and incubators. We also conduct cleanroom certification to ISO and PIC/s guide based on cgmp offering NATA traceable certification services as well as a bio-decontamination service which enables an environmentally friendly technology with an effective six log kill rate. We believe in supplying reliable equipment and services to our customers. Our product specialists and Subject Matter Experts (SME s) have much experience and knowledge over the products and industries we serve and offer great technical support to our clients in relation to their specific processes and applications. LAFtech delivers innovation in the servicing and delivery of controlled environment solutions. EMStech a division of LAFtech is the complete environmental monitoring solutions company for your critical applications. A division of Laftech Service Department Equipment Service Mechanical Testing Environmental Monitoring Solutions Design and Installation Fume Extraction Forensic Laboratory Equipment Jason Kelly - EMStech Manager Cleanroom & Clean Air Device Certification (NATA) An Australian Company Est: 1987 ISO 17025, & Eco Warranty General & Specialised Laboratory Equipment CO2 Incubators Decontamination Services ihp bio decontamination Isolation Rooms Pharmaceutical Isolators Gloveboxes Biological Safety Cabinets Cytotoxic Cabinets Laminar Flow Cabinets Our mission is to provide our customers with the most technologically advanced monitoring systems and solutions that safeguard the process and provides users with real-time sensor data and trends assisting them in keeping control of their facility while maintaining product integrity to the highest regulatory standards 6 Accredited Laboratory LAF Technologies Pty Ltd. Equipment Sales & Service: Tel: Vic: Qld: _fenstar.com.au

Ease of Use. Data at Your Fingertips LMS PHARMA

Ease of Use. Data at Your Fingertips LMS PHARMA LMS PHARMA Ease of Use LMS Pharma was designed with an ICON driven user interface which greatly simplifies the user experience. Color coded status and unique shaped ICONS enhance the already intuitive