The most versatile testing solution available

The SAIL is Bonfiglioli’s new automated inspection laboratory for different container types, sizes, and content bringing together CCIT, AVI and HGA technologies is an all-in-one machine that is suitable for in-process control, clinical trials, and laboratory use.

HIGHLIGHTS

 SAIL modular structure provides adequate flexibility upon all 3 of testing technologies:

– AVI (Automatic Visual Inspection)/ SAVI a collection of images is acquired using high resolution matrix cameras under designed illumination conditions.

– CCIT (Container Closure Integrity Testing) non-destructive integrity testing in packages by Vacuum Decay Method.

– HGA (Headspace Gas Analysis) inspection process is based on the Tunable Diode Laser Absorption Spectroscopy (TDLAS) method which accurately quantifies gaseous concentration levels.

• All in one Industry 4.0 based
   laboratory
• Ergonomic workstation
• Scientific and objective inspection
• 100% traceability
• Time & cost saving

SAIL modular structure provides adequate flexibility for all 3 testing technologies:

– AVI (Automatic Visual Inspection) /SAVI

– CCIT (Container Closure Integrity Testing)

– HGA (Headspace Gas Analysis)

The testing methods conform to current pharmaceutical regulations, such as FDA 21 CFR Part 11 and EU Annex 11USP General Chapter <790>ASTM F2338-09USP General Chapter <1207>EU Annex 15 and GMP requirements.

Contact our offices today to learn more about the SAIL.

Table top Container Closure Integrity Tester

The LF-S11 by Bonfiglioli is a countertop compact machine, designed for Non-Invasive, Non-Destructive Container Closure Integrity Testing of diverse types of Pharmaceutical Containers filled with liquid, lyo, powders, etc..

Suitable for In-Process Control and Laboratory use without altering container and/or content features.

The integrated software system allows full compliance to provisions stated in FDA 21 CFR part 11 as well as EMA Annex 11.

3 Configurations of the machine available to meet all specific requirements:

– BASIC, for most of the container formats 

– XL, designed specifically for large formats (more than 100ml)

– SY, designed for syringes, carpoules including automatic plunger stopping device

Equipment test method complies with:

– FDA Guidance for Industry “Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products”.

– United States Pharmacopoeia General Chapter «1207» “Packaging Integrity Evaluation”.

– EU Guidelines to GMP Medicinal Products for Human and Veterinary Use – Annex 1 “Manufacture of Sterile Medicinal Products”.

– PDA Technical Report No. 27 “Pharmaceutical Package Integrity”

All dedicated test chambers are designed according to the container characteristics for a maximum of leak detection sensitivity and are monitored by specially developed electronics during the testing process. The group has been recently redesigned to obtain improved functionality (quick

 single-handed opening and closing). It is directly installed onto the Testing Chamber supporting flange and it is composed by: – A fixed bottom part; – A removable top cap (upper part) that allows plugging up the testing group corresponding to Container loading and unloading operations.

HOW IT WORKS

The test chamber fixed bottom part is equipped with a mobile piston, plunger stopping device (PSD), having vertical motion between two limit positions, “upper” and “lower”, and having a section equal to that of the PFS plunger.

The initial vacuum, generated in the test chamber, produces an upward movement of the PSD.

The same “upper” position is kept until the second reading; at that time, the action of a dedicated pneumatic actuator provides for exhaust of vacuum in the test chamber bottom area and produces the PSD downward movement towards the “lower” position.

For more information, please call our office and we’ll be happy to assist.

Lunch and Learn webinar series

If you want to learn more information about the equipment and machinery that is manufactured by the companies we represent, To meet the team of engineers behind the projects and hear their thoughts and opinions on some of the critical processes that they were challenged with, then the Lunch and Learn Webinar Series will be a good place to start.

You’ll also have the opportunity to learn about the key features of specific products and equipment and what is their proper application.

Among the most viewed topics we discussed on our webinar were:

  • The never ending debate of Injection Molded Unit dose delivery systems versus the Blow Fill Seal containers;
  • The discussion of proper storage methods, Standalone Freezers or Consolidated chambers;
  • The presentation on the Key Factors of the development of a Cleaning Strategy;
  • The often overlooked issues with quality control equipment and solutions;
  • A nice presentation of the applicability of Torque testers on the Pharma Market;
  • The important part that conveyance plays in your production efficiency;
  • and you can find a lot of case studies and machine demos in each episode of the Lunch and Learn Webinar Series.

Our Webinar Broadcasts are always public, free to attend and comment. In order to receive updates about any upcoming streams of our Webinar you can Subscribe to our Website, Connect with our LinkedIn Page, or Subscribe to our YouTube Channel.

If you have any special Requests about some topic being discussed on the series, have questions about any previous streams or you’d like to inquire more information about any aspect of the series, please send an email to Marko via MarkoV@Lsi1.com

Happy New Year!

New Year is upon us again.

So accept these season’s greetings that we happily send. Thank you for always providing great solutions and for being the one to bring forth excellent resolutions and challenges to our team.

You are valued as our business partner.

To our team you bring so much wisdom, fun and laughter.

Happy New Year from the LSI Team.

r is upon us again.

So accept these season’s greetings that I happily send. Thank you for always providing great solutions and for being the one to bring forth excellent resolutions.

You are valued as a business partner.

To our team you bring so much wisdom, fun and laughter.

Happy New Year from the LSI Team

Happy Holiday Season

May the Holiday season fill your home with joy, your heart with love, and your life with laughter.

Wishing you peace, love, and joy this Holiday Season and throughout 2019.

Wishing you Holidays filled with fun and laughter, and very best wishes for a prosperous new year.

Merry Christmas and Happy Holidays

As the holiday season is upon us, we find ourselves reflecting on the past year and those who have helped to shape our business. It’s been quite a year for us all!
We hope that 2019 has been just as memorable for you, your colleagues and your loved ones. We look forward to working with you in the years to come.

Seasons Greetings. May your holidays be merry and bright.

Let us take this opportunity to thank you for all your faith and dedication towards our company, on this Christmas.

Hope your bond lasts forever.

Merry Christmas!

Walk in Chambers – The future of storage

Bahnson Environmental specialties designs, manufactures, installs, and services custom chambers of all types and sizes, for a wide array of applications, including: GMP Shelf-Life Testing and Storage, Dry/Moist and Cold Storage for Seed and Agricultural Products, Nutritional Supplements, General Materials Testing, Mold and Fungal Incubation, Photography Storage, Concrete Curing, Roll-In Bottle Incubation Chambers and Cold storage solutions.

They are part of the EMCOR group a fortune 500 company with over 40 years of extensive experience in the field, providing the most resource-saving technologies in liquid-circuited cooling systems to ultrasonic humidification.

When custom solutions are required, the engineering team has the training and experience to ensure that optimal performance does not sacrifice energy efficiency. In their comprehensive experience they have encountered facilities that had lost multi-million dollar worth of research due to freezer or consolidated chamber failures.

In the recent years, Bahnson Environmental have become advocates for installing a consolidated walk in chamber over solving your storage problems by adding a new stand-alone freezer and ending up with the so called freezer farm.

The debate of Freezer farm vs Consolidated Storage has been showcased on our webinar series. Some of the more specific conclusions reached on that show were:

  • Freezer Farms are cheaper to be bought and are easier to be installed
  • Freezers are more prone to failures over Consolidated walk in chambers
  • Freezer farms have significantly higher maintenance fees
  • Freezers are less power efficient than consolidated walk in chambers
  • Freezers often have no to low fail safe assurance technology
  • There are no minimal or maximal space requirements in installing walk in chamber
  • Under some external third party studies 4 common ultra low freezers have the same power efficiency grade as a walk in chamber 20 times that size in volume

Bahnson’s standard and custom environmental chambers / rooms include:

  • Walk-in temperature and humidity chambers
  • Walk-in warm rooms
  • Walk-in cold rooms
  • Walk-in freezers
  • Walk-in incubators
  • ICH stability chambers
  • Shelf life study chambers
  • HEPA filtered clean cold rooms
  • HEPA filtered clean warm rooms
  • Test chambers
  • Plant growth chambers
  • Shelf lighted rooms
  • 1% and 2% dry rooms
  • Other low humidity dry rooms

These are just a sampling of room types included in the walk-in environmental chamber series.

In the pharmaceutical market, Bahnson is determined and focused on stability rooms, that strive on meeting and exceeding the ranges and uniformities of the ICH has allowed Bahnson to become the recognized leader in chamber design, construction, and stringent performance qualification in support of our clients’ validation.

Bahnson is also a well know brand that supplies universities, medical schools, and industrial customers with chambers requiring uniform dependable room conditions for storage and testing experiments.

Their comprehensive resume includes some of the largest installations of multiple environmental rooms in notable research buildings on campuses throughout the US.

 

Get in touch with our project engineer at 800-829-5741.

 

Fully automatic labelling system for glass or plastic syringes

The Newman NVS2 Labelling Machine is a fully automatic, self-adhesive labelling system designed for glass or plastic syringes and other similar cylindrical containers.

 

The NVS2 is a fully automatic, self-adhesive labelling system designed for glass or plastic syringes and other similar cylindrical containers.

The system was specifically designed to meet the requirements of the international pharmaceutical industry and all the regulatory bodies, including the FDA.

 

The product is fed into a vibratory feed track either directly from the customer’s existing upstream equipment, by hand, or optional syringe feeding system. From the vibratory track, product enters an indexing starwheel for transfer to the label applicator assembly.

For accurate label placement each individual label is detected at the labelling point as it passes beneath a sensor, (product orientation available as an option), at which point the label feed is activated. The leading edge of the label is driven off the backing web at a linear speed which matches the container speed. This ensures highly accurate label placement.

 

These are the key Features of the machinery:

  • Stainless steel construction
  • cGMP design
  • Stepper motor drive for label web
  • Straight label arm, adjustable in all axes
  • Accurate label placement
  • Indexing star wheel principle
  • Interlocked guarding
  • Stainless steel vibratory feed track
  • Allen Bradley or Siemens PLC controls
  • Two line LCD message display
  • Full variable speed drives
  • Left or right label formats available
  • Quick release change parts design
  • Infeed queue switch control

 

Also the Newman NVS2 Labelling Machine comes with a lot of optional extra capabilities:

  • Hot foil, thermal transfer, laser and inkjet printing options
  • Missing overprint detector
  • Missing label detector
  • Bar code reading systems
  • Vision Systems for OCV / OCR / barcode
  • Reject station for missing label, faulty / missing overprint and barcode with reject verification
  • Validation documentation package and implementation
  • Easisplice 470 module enables reel changes without labelling downtime
  • Product orientation to label
  • De-nesting systems for product feeding
  • Manual or online product feeding
  • Back-up queue switch control

 

Our company provides a lot of equipment, packaging and services regarding glass or plastic syringes. Get in touch with our product specialists to inquire further information 800-829-5741

CONTAINER CLOSURE INTEGRITY TESTER

The LF-SMH by Bonfiglioli engineering is an offline multi head container closure integrity tester.

The Machine is suitable for laboratory applications, statistical purposes as well as off-line testing.

The Measurement System comprises applying a pressure differential into an airtight Testing Group enclosing the Container (Patent No. 1225063 of 13-9-1988). The test objective is to detect Container leakages by measuring the reached pressure level as well as the pressure change over test time.

The Measurement System follows the approved industry standard “ASTM F2338-09”

The Test method is a Recognised Consensus Standard by the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), effective March 31, 2006

 

This machine is capable of testing up to 8 units per session and the complete cycle from start to finish is concluded in less than 90 seconds. The unique design of the machinery allows the users to handle multiple types of containers like Vials, Pouches, MDPI, MDI, IV Bags, Flowrapped Device, Bottles, Liquid Forms.

This machine is also capable of testing empty containers used for injection molded filling, filled containers whether they are closed, sealed or open.

Beside liquids, the LF-SMH can also perform tests on containers filled with powder or semi-solid content. This laboratory leak detection tester emphasizes the vacuum decay testing method which when operated at full speed in appropriate testing environment can perform up to 20 calculations per minute.

 

For more information regarding the LF-SMH or for other vacuum decay testing solutions please reach out to our product specialists at 800-829-5741

FGW: Free Standing Washers

The NEW Fedegari FGW is a glassware washer unit for laboratories, capable of performing a complete washing cycle composed of the following phases: pre-washing, washing, rinsing, acid/chemical additives rinsing, purified/DI water rinsing, drying and cooling.

Thanks to its dedicated process controller and to its special design that allows steam to be injected directly in the chamber, this machine is suitable for use in many different applications

Key Features
  • High level of programming and application flexibility with fully configurable cycles
  • Full traceability and documentation in order to meet the most stringent worldwide safety and quality standards
  • Sanitary components and CIP to ensure a perfect washing
  • Energy saving thanks to the use of steam and the recirculation of the water
  • Vertical automatic sliding doors, effortless pneumatically operated
  • Doors, chamber and piping components made of sanitary AISI 316L stainless steel
  • Ergonomic loading height
  • Built-in steam generator (0.5 bar)
  • Stainless steel (AISI 316L) modular internal rack with automatic connection to hydraulic circuit

Click here to see the product brochure, alternatively:

Contact us at  800-829-5741 for more info.

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