Bahnson Standard Reach-In Chambers

The Bahnson ES2000 reach-in stability chambers is provided in four standard sizes, ranging from 12 to 144 cubic feet, each offering a wide variety of temperature, humidity, and light (photostability) capabilities.

 

Bahnson Environmental Specialties’ typical reach-in chamber uses include ICH stability, shelf life studies, photostability (ICH Q1B Option 1 and 2), incubators, plant growth, tissue culture storage, freeze-thaw, blast freezing, and other product testing and/or stability storage.

Chambers can also be designed to meet classified storage requirements (Class 1 Div 2), HEPA filtered cleanroom standards (Class 100-10,000), cycling/stress test requirements, or other special design requirements on request.

BES offers a range of environmental test and stability chambers designed for high demand testing, processing, conditioning, or growth applications.

The ES2000 product line includes six standard models. Standard temperature capabilities range from 2° C to 70° C, with controlled humidification, lighting and CO2 available.

A 13-month warranty on parts and labor is included with all ES2000 stability chambers. An optional five-year compressor warranty is also available.

More info about the ES2000 can be found on Bahnson’s website: http://www.eschambers.com/products/standard-reach or by contacting our representatives.

COZZOLI RFP SERIES – MULTI-CONTAINER FILLING MACHINE

 

The redesigned RPF Rotary Piston Filling Machine delivers advanced performance with fast, flexible, and reliable operation. The rotary piston fillers are automatic machines specially designed to accommodate a multitude range of products of most viscosities at high production speeds of 600+ per minute. The machine comes in various frame sizes and models; from four to thirty-six filling nozzles. The overhead driven pistons with fine fill piston adjustment provide ±0.5% fill accuracy.

The cylinders and pistons are easily removable for cleaning or changeover to other sizes. They come with new features that include improved star wheel drive system with factory set overload clutches and improved spiral drive clutch, that offer precise adjustment without the need of re-adjustment. The improved piston drive cam assembly ensures quiet operation, enhanced precise fills and an upgraded volume adjustment mechanism with maintenance free linear bearings

This machine is designed to perform multiple functions in a Class 100 clean room environment. It will provide many years of reliable service while being easy to maintain and conducive effective laminar air flow.

Cozzoli machines come pre-equipped with hood isolation and laminar flow in mind, utilizing the least amount of space for use in a clean environment. This machine will fill liquids, then stopper the containers using full or partial stopper insertion.

 

Contact us regarding information on any Cozzoli machinery and we’ll gladly assist you find the perfect machine for your production needs.

The Newman VAL550 Labelling Machine

The Newman VAL550 is a high-speed labelling system for pharmaceutical containers, including ampoules, vials, syringes, bottles and cartridges. Combining the latest electronic systems with high quality mechanical engineering, the VAL550 provides accurate and reliable high speed labelling.

 

Designed specifically to meet the requirements of the international pharmaceutical industry and all of the industry’s regulatory bodies, including the FDA.

Containers are fed either from trays (off-line operation) or automatically from upstream machinery (on-line operation) to the VAL550 infeed starwheel. Container flow is controlled via a simple ‘blade’ gating assembly. Containers pass to the labelling point, a sensor triggers the label feed, the leading edge of the label is driven off the backing web at a linear speed which matches the container speed. This ensures smooth, accurate placement on the container surface. The container, gripped between an applicator belt and presser pad, is controlled as the entire label is pressed firmly in place, ensuring high registration accuracy. The container, gripped between an applicator drum and presser pad, is controlled as the entire label is pressed firmly in place, ensuring high registration accuracy.

The key features of the VAL550 are:

  • ‘Auto-teach’ label length facility
  • Non-synchronous container feed without scroll feed
  • cGMP design
  • Positive-accept security system
  • Container feed by tray-in, tray-out feed, or in-line configurations
  • Accurate label application
  • Gentle container handling
  • Extreme versatility for different applications
  • Full regulatory compliance
  • Hot foil coding unit
  • Digital scales for rapid container changeover
  • Fully validated security with critical device checking
  • In Process Control – system verification without production stoppages
  • Stainless steel 304 finish
  • Validation documentation and implementation package
  • Auto-reject system for both incorrect label data and missing label detection with reject verification
  • Touch screen HMI with key switch access run mode and set up mode
  • Counter package with full count reconciliation
  • End of web detection
  • High performance stepper for motor label web drive

 

The Newman VAL550 is a very efficient system with the highest possible build quality. To request further info regarding this or other Newman products please contact our representatives.

Mesa Labs is the Expert at Low Flow Gas Measurements

 

Advances in microtechnology and other precision processes are driving industry to need high-accuracy measurement of very low flows. However, measuring very low flow rates (<5 sccm) is difficult for most technologies on the market. The measurements are often slow and can be difficult to obtain stability for laminar flow or thermal technologies. Additionally, the signal is so low that you will experience higher uncertainty when using a non-primary standard.

Mesa’s DryCal 800-3 combines our innovative dry, primary technology with intensive gravimetric calibration to create a flow standard that easily measures down to 0.5 sccm with an industry-leading 0.25% accuracy. Having a flow standard designed for ultra-low flow measurements means that measurements will be faster, and overall accuracy will be higher. Our comprehensive, multi-day calibration process guarantees that the gas flow for your most critical processes is accurate.

When gas flow rates are low, the total volume of gas in the system is low. This means that higher errors could be more catastrophic to the end product or process. Flow rates of a few sccm are common in critical processes in the medical and semiconductor industries. You want to be sure that you are trusting your critical processes to trusted standards. All our DryCal standards are NIST-traceable and ISO-17025 certified in our NVLAP-accredited laboratory.

Click here to learn more about the Science of DryCal.

Contact us today on how we can help streamline your low flow processes.

 

FCDV – Bio decontamination unit – Fedegari Group

 

The Fedegari Bio – Decontamination unit (FCDV) is a reliable, flexible solution for equipment not suitable for thermal sterilisation. Easy validation and process optimisation via the Thema 4 system enables our customers the peace of mind that the Fedegari FCDV is the first choice in bio-decontamination. It comes pre-equipped with the built-in FHPV- Fedegari Hydrogen Peroxide vaporizer most popular for its antibacterial, antimycotic and antiviral properties, that are well known and scientifically documented.

 

With the FCDV bio decontamination unit you can bring inside the clean rooms all those products and instruments that cannot be thermally sterilized. Surface bio decontamination of the load is carried out with vaporized hydrogen peroxide – H2O2.

Among the most reliable sporicidal agents, vaporized hydrogen peroxide (H2O2) is nowadays one of the most popular.

 

This machinery will be exhibited at the Achema – 11th – 15th June –  Hall 6.1 – Booth B68.

 

Please contact our representatives for more information or presentation of the key features of this equipment

 

fedegari.com

Vacuum Decay Testing Method

Tune in on May 16th 11:45 AM CST for a presentation on Vacuum Decay Testing Method. VDM is a non-destructive Container Closure Integrity (CCI) testing practice applicable to most pharmaceutical package systems. Our presenter is going to be Peiro Polastri, Regional Sales Manager for ALPS & Bonfiglioli.

This will be important content for those interested in upgrading to a more sensitive, non-destructive quantitative leak test vs. an old school dye ingress test, that is slow, labor-intensive, qualitative and destructive.

Bonfiglioli Engineering developed the VDM system in accordance with the ASTM approved test method F2338 that is recognized by Food and Drug Administration (FDA)as a consensus standard for pharmaceutical packages integrity.

FDA rolls out action plan to improve medical device safety

The FDA released The Medical Device Safety Action Plan April 17, which outlines agency strategies to better monitor and regulate the safety of medical devices.

The agency hopes the plan will spur more innovation for device safety, help identify safety risks earlier, and keep physicians and patients more informed.

“Our aim is to make sure that the new advances in technology that are enabling better capabilities and benefits are also harnessed to bring added assurances of safety, so that more patients can benefit from new devices and address unmet needs,” FDA Commissioner Scott Gottlieb, MD, said in a statement about the program.

Here are five goals the agency seeks to achieve through the plan.

  1. Establish a robust medical device patient safety net in the U.S.
  1. Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations
  1. Spur innovation toward safer medical devices
  1. Advance medical device cybersecurity
  1. Integrate the FDA Center for Devices and Radiological Health’s premarket and postmarket offices and activities to advance the use of a total product life cycle approach to device safety

To learn more about the action plan, click here.

Source: https://www.beckershospitalreview.com/supply-chain/fda-rolls-out-plan-to-improve-medical-device-safety.html

LF at Interphex

 

Thank you for stopping by LF’s Booth at the Interphex.

 

Pharmaceutical packaging machinery provides quick and efficient solutions for preparing cosmetic, health and beauty, pharmaceutical, and nutraceutical products for distribution.

The newest pharmaceutical packaging equipment actually combines filling, sealing, and packaging into one system. As such, packaging industry leader LF of America is now the complete source for all contract filling and packaging services.

And the latest improvements to our pharmaceutical packaging machinery only further separates us from our competitors as the perfect partner for all kinds of companies.

For custom unit-dose packaging to filling cosmetics, health and beauty, OTC, pharmaceutical, and nutraceutical products, visit LF of America website.

https://www.lfofamerica.com/

Interphex 2018

 

We are proud to announce the presence of our manufacturers to this years Interphex Expo that’s taking place this week at the Javits Center in New York City.

INTERPHEX has proven to be the place to find all of the State-of-the-Art Solutions you need to Cost Effectively Develop and Manufacture Quality Product. INTERPHEX is the premier pharmaceutical, biotechnology, and device development and manufacturing event where you can “Experience Science through Commercialization”

 

If you are planning on attending this tradeshow please take note of our manufacturers Booths and the equipment that they will be exhibiting on the show.

 

Bahnson Environmental Specialties, LLC. – Raleigh, NC
Presenting their complete line of Walk-In and Reach-In Controlled Environmental Chambers designed for diverse pharmaceutical applications including HEPA Filtered Cold Rooms, modular and traditional Clean Rooms, Stability Chambers exceeding ICH guidelines and high capacity -75°C Cascade low temperature storage chambers. BES will present information on 3  of their unique High Volume Freezer designs for the biorepository storage market that allow reduced dependence on small unitary freezers.

Come see Bahnson at Booth: 1945

 

LF of America, the US subsidiary of Lameplast group is going to exhibit at INTERPHEX 2018!

Lameplast Group is a worldwide leading manufacturer of plastic containers for the pharmaceutical and personal care industries. With more than 35 years of experience and a US branch located in Florida, the companies of Lameplast Group offer true turn-key solutions including the supplying of fully-automated semi-automated filling and sealing machines.

See their machinery and get some packaging samples at their BOOTH: 2364

Cozzoli Machine Company will be exhibiting at INTERPHEX 2018.

As a single source provider for individual components to fully integrated lines, they offer production solutions for every application, from pharmaceutical, cosmetic, e-liquid, health, beauty aids, personal care, food and beverage, chemical, paint and industrial products. Featured machines include the RPF8 Rotary Piston Filler, the FSV50 Mini Monoblock, the GW24 Ampule/Vial Batch Washer, and the PF2-IS powder filler. Cozzoli will also be showing their tabletop F400XSS Liquid Filler.

Stop by to see our latest technology in Booth 2805

To set up a booth meeting, please contact Cozzoli at (732) 564-0400 or sales@cozzoli.com. We look forward to seeing you at the show!

Claim a free pass for the exhibition HERE!

 

Fedegari Announces the Next Sterilization and Aseptic Processing Week.

 

There is no doubt that for achieving the highest performances with our sterilizers you need to fully understand the process also from a scientific standpoint. This is the reason why we have Fedegari teaming up with Jim Agalloco in order to offer you the most effective education.

 

This year, we are glad to inform you that Jim will hold two different courses in Zurich (Switzerland), covering all the subjects relevant to sterilization and beyond, as following:

 

STERILIZATION: PRINCIPLES AND VALIDATION

ASEPTIC PROCESSING: A COMPREHENSIVE REVIEW

Take Either Course or Save on Both

MAY 28 – JUNE 1, 2018, ZURICH, SWITZERLAND

 

The tentative schedule for the course can be found on this location: http://www.fedegari.com/en/agalloco-associates-2018-training-offerings/

 

If a Euro trip is out of the picture for your facility, please get in touch with our representatives and we’ll make sure to host several training sessions on US soil.

 

Don’t miss the opportunity to join us at these classes and book your place by clicking here!