PRODUCTS
HIAC 9703+ Pharmaceutical Liquid Particle Counter
HIAC 9703+ liquid sampler and PharmSpec Software for Parenteral Drug Final Product Testing to USP<787>, <788> & EP2.9.19 :
PharmSpec Software works with the HIAC 9703+ liquid particle counter system to test parenteral products for sub-visible particle content using light obscuration in accordance with USP<787>, <788> and EP 2.9.19.
Flexible calibration at multiple flow rates improves ease of sampling for varying sample viscosities and volumes.
Ease of use and data integrity are prioritized in PharmSpec with features such as login credentials controlled by Microsoft Active Directory, multi-level user rights, automated pass/fail compendial reporting, comprehensive audit trail, and auto-flush routines for improved walkaway operation. In addition to the built-in compendial test routines, user-defined SOPs can be programmed into the counter using PharmSpec Software’s Procedure Builder.
MET ONE HHPC+ Handheld Air Particle Counters
MET ONE HHPC+ Series handheld particle counters allow easy ISO Class 5 to 7 monitoring in hard-to-reach places. Lightweight with a high-resolution display, these handheld counters are ideal for routine monitoring of controlled environments and mini-environments, easy filter leak troubleshooting for particle-contamination issues, spot-checking critical areas, and targeting particle generation within process equipment.
ISO 14644-1 industry standard
CFR 21 Part 11 compliance enabled
0.3 μm – 10.0 μm particle detection
2-6 channel detection
Single-hand operation
PC access to particle counting data via Ethernet, USB, or cable for data transfer options
MET ONE 3400+ Series GMP Cleanroom Routine Environmental Air Particle Counter
MET ONE 3400+ Series Portable Airborne Particle Counter allows users to load their routine environmental monitoring SOP sampling map and sampling configuration for each location directly into the counter, so that the SOP becomes an interactive sampling map directly on the counter screen to guide users doing daily sampling. This helps reduce training requirements and sampling data errors/omissions.
MET ONE 6000 / 7000 Remote Air Particle Counter
MET ONE 6000 air particle counters are a compact design with flexible sizing, flow rate and communication options that address the specific needs of cleanroom environments within the pharmaceutical, semiconductor, hard disk drive and flat panel display industries providing ISO 21501 accuracy for continuous particle monitoring. Reduce initial installation cost with MET ONE 6000 remote air particle counter’s integrated multi-parameter measurements.
The MET ONE 7000 provide high accuracy non-viable particle monitoring for cGMP/FDA compliance. Stainless steel wash-down resistant enclosure and VHP tolerant optics protect the instrument while ISO 21501 certified calibration assures accurate continuous monitoring in aseptic and sterile pharmaceutical production environments.
Facility Monitoring Systems (FMS)
Scalable Facility Monitoring Systems (FMS) that can be configured to meet a wide spectrum of cleanroom management needs for various industries—including pharmaceutical production. Among parameters that can be efficiently and reliably monitored using a Beckman Coulter FMS are non-viable/viable air sampling, differential pressure, air temperature and relative humidity. All of the company’s FMS solutions are based on an open-architecture platform designed to enable easy, streamlined integration with existing customer systems (SCADA). Each instrument is built around proven MET ONE technology, including the portable MET ONE 3400 series for routine monitoring and cleanroom classification, as well as the 6000 and 7000 series of fixed, non-viable air particle counters. MET ONE software platforms feature intuitive interfaces to help make them easy to use, thereby reducing the potential for human error that can occur with manual SOP monitoring. To avoid losses from product contamination, stack lights, audible alarms and process shutdown signals from a Beckman Coulter FMS can prompt an immediate production line response whenever an excursion happens. In addition, to help centralize reporting and simplify EUGMP/FDA compliance (e.g., for ISO 14644 and 21 CFR Part 11), Beckman FMS data can be integrated into a single-release, electronically signed paperless report.
Frequency Modulation Spectroscopy (FMS) Headspace analyzers
• FMS-Oxygen Headspace Analyzer
• FMS-CO2 Headspace Analyzer
• FMS-Pressure/Moisture Headspace Analyzer
• FMS-Water Activity Headspace Analyzer
Frequency Modulation Spectroscopy (FMS) is utilized by LIGHTHOUSE laboratory instruments to determine the amount of gases within the headspace of pharmaceutical containers. Using laser absorption, light from a near-infrared laser is tuned to match an internal absorption frequency of various molecules and passed through a glass sample container in the headspace above the product. The amount of laser light absorbed is proportional to the concentration of the specified gas in the headspace. The rapid and non-destructive nature of the analysis allows for multiple measurements on the same sample over time, which yields more accurate results. Additionally, this prevents waste, which saves costs on both waste disposal items and valuable product. The benchtop FMS Analyzers are straightforward to use, meaning operators do not require special expertise to use these robust, portable devices, and accuracy does not depend on operator skill. The benchtop headspace gas analyzers can be used throughout the entire product lifecycle, from development to QC laboratory applications to at-line, in-process control of headspace gas / water levels in production.
Pulsar Machines
Container Closure Integrity (CCI) inspection of pharmaceutical products:
PULSAR line of machines characterize the physical headspace conditions of product samples in a reliable, compact, and flexible platform. PULSAR Headspace Inspection System can provide automated, 100% inspection of headspace oxygen, moisture, and carbon dioxide levels in sealed parenteral containers, while our PULSAR Headspace CCI Inspection Lease System offers a small footprint, fast delivery solution for the 100% CCI inspection of pharmaceutical product on a per project basis.
Heated Circulating Baths; Refrigerated Circulating Baths & Immersion Circulators
A heated circulating bath is ideal for applications where temperature control is paramount. Whether you’re conducting sample prep using the reservoir or seeking to maintain the temperature inside your jacketed vessel via fluid circulation; Thermo Scientific Sahara heated bath circulators allow you to create the environments your applications need for precise, reliable and repeatable results. Thermo Scientific Arctic and Glacier Series refrigerated bath circulators offer outstanding cooling power, expansive temperature ranges, powerful force/suction pumps, and sophisticated digital control technology designed to ensure accuracy and reproducibility of your liquid temperature control procedures. The stainless steel reservoir is offered in multiple capacities with a variety of reservoir openings and depth dimensions for maximum application flexibility.
ThermoChill & ThermoFlex Recirculating Chillers
Thermo Scientific recirculating chillers support a variety of applications, from lab bench to large manufacturing processes. For critical applications that require large-batch process cooling, a recirculating chiller offers a versatile, dependable investment, ensuring years of steady, reliable operation. Easy-to-use interfaces and simplified internal engineering means that whatever your task or field of work, you can focus on cooling your application and not your output.
Water-to-Water Heat Exchange System
Water-to-Water Heat Exchangers Take advantage of an existing in-house water system for heat removal. Thermo Scientific™ System Water-to-Water Heat Exchangers use less energy and cost less to operate than traditional compressor-based chillers. They provide a clean, stable, controlled, closed-loop water cooling system that rejects the process heat into an existing in-house facility water supply. This eliminates the problems associated with the direct use of in-house water such as insufficient or fluctuating flow, changing pressure, poor water quality and temperature instability. Cooling capacity is based on a 10°C temperature differential between the cooling water supply and the cooling fluid flowing from the System to the instrument being cooled.
Pharmaceutical Standards
We are proud to partner with the leading providers of pharma standards:
USP, EDQM, BP, NIBSC
We offer over 10,000 standards.
You can find them in our website by searching for “USP-” or “EP-” in the cat # field:
Discover Rhenium’s Chemistry catalog, leading offer of over 700,000 products.
HPLC Columns
ACE manufactures a range of cutting edge U/HPLC chromatography. ACE portfolio provides a premium quality product with unique phases that separate what other columns cannot.
The range includes novel and traditional stationary phases based on ultra inert silica for excellent reproducibility
