Non-Destructive Integrity Testing of Containers from Bonfiglioli

The LF-S11 Machine by Bonfiglioli Engineering is designed for Non-Destructive Integrity Testing of Containers and it is suitable for laboratory applications, statistical purposes as well as off-line testing.

Measurement System comprises applying a pressure differential into an airtight Testing Group enclosing the Container. The test objective is to detect Container leakages by measuring the reached pressure level as well as the pressure change over test time.

Call for more details 1 414 671 3332

Warehouse Mapping-Mesa Labs

The changing weather can greatly impact certain areas of your warehouse, and these temperatures changes may affect your product. Will temperature mapping your warehouse only once provide enough information to understand the storage conditions in the warehouse during the coldest time of the year (high use of heating) and warmest time of the year (high use of A/C) or should your warehouse be mapped multiple times so that your products are not potentially damaged?

Mesa’s Compliance and Validation Services experts will work with you and your team to review every potential variable that may impact the viability of your product. We will determine the risk factors by considering all HVAC activity and control, loading dock location and activity to develop criteria for and execution of a thermal mapping.

We will also establish acceptance criteria. The temperature and relative humidity acceptance criteria for each product is determined by testing conducted per the FDA Guidance Document – Stability Testing of New Drug Substances and Products, or similar guidance. The data logging system will be determined, a diagram will be developed, and the length of the study will be defined. Finally, Mesa experts will place the data loggers in the appropriate locations throughout your warehouse and collect the resulting data.

By performing regular mappings of your warehouse, you can greatly reduce the risk to your products by varying temperatures when the seasons change.

TAMPER EVIDENT LABELLING SOLUTIONS TO MEET THE REQUIREMENTS OF THE FALSIFIED MEDICINES DIRECTIVE (FMD)

The Falsified Medicines Directive (FMD) 2011/62/EU will come in to force by February 2019. This directive requires two mandatory safety features that will enable medicines to be verified and authenticated along the supply chain:

Tamper evident features on the carton. A unique identifier (2D data matrix code and human readable information) on the carton.

Newman’s range of automatic tamper evident labellers enables our customers to meet these new regulations, whilst also providing high levels of flexibility, quality and reliability. Designed to apply a range of self-adhesive tamper-evident, anti-counterfeit and hologram labels, a single machine can handle a wide range of carton types and sizes without the need for change parts.

The CTE350 is a tamper-evident labeller that operates at speeds of up to 350 cartons per minute and, measuring just over 1m in length, is ideal for integrating in to lines where space is at a premium. The CTE450 operates at speeds of up to 400 cartons per minute and, with track and trace serialization capability, meets the requirements of the Falsified Medicines Directive.

Specifically designed for healthcare applications, the CTE350 and CTE450 have a stainless steel/GMP construction and are available with full Validation Documentation Package. In addition, Newman Labeling Systems is able to integrate different print and inspection systems to meet our customers specific requirements.

As a design and manufacturing company, Newman thrives on the challenges that our customers bring to us! If you have a specific labeling requirement then please let us know.

 

VISIT NEWMAN IN 2018

2017 has been a busy year for Newman Labelling, but weâ??re already planning ahead for 2018 and have booked shows in Europe and the USA:

Achema

11 to 15 June 2018
Frankfurt am Main, Germany

PPMA Show
25 to 27 September 2018
NEC, Birmingham, UK

PACK EXPO International
14 to 17 October 2018
Chicago, Illinois, USA

We hope you can visit our stand and see one of our world beating labelling systems in action.

2017 ISPE EUROPE PHARMA 4.0 CONFERENCE

Pescantina, Verona, Italy, 23-24 November 2017-11-14, tabletop #23

 

What added value will automation bring to the current manufacturing processes for pharmaceutical products? What opportunities will the end-to-end integrated system of all computerised systems, vertically and horizontally, add to pharmaceutical operations? All these questions and more will be answered during the 2017 ISPE Europe Pharma 4.0 Conference – “From Industry 4.0 to Pharma 4.0”.

 

On behalf of TASITEST Packaging Test & Inspection, the leading specialist on leak testing, measurement and inspection, Bonfiglioli Engineering’s Product & Application Specialist, Mr. Giovanni Golinelli, will be welcoming you at tabletop #23 where you can discover BONFIG LF-S, a leak detection machine suitable for laboratory applications, statistical purposes as well as the off-line testing of diverse pharmaceutical packaging including: Vials, Monobloc, PFS Nest, Pouches, IV Bags, Flowrapped Devices, FFS, BFS, Carpules, Pre-Filled Syringes, Bottles and Ampoules.

 

 

The complete and detailed agenda of the event can be consulted at https://www.ispe.org/conferences/2017-europe-pharma-industry-4-0-conference

 

ST100 Recirculating Hot Air Tunnel by Cozzoli

The ST100 recirculating hot air tunnel is designed for drying and sterilizing glass containers, particularly when used in a production line in the pharmaceutical industry. The tunnel uses vertical hot laminar airflow, under a class 100 air protection hood, to ensure the glass containers are not contaminated by any outside environmental contagions.

 

 

 

Introducing Bonfig’s Lasercube

We recently introduced the BONFIG LASERCUBE to the US market, a bench top system for performing Headspace Gas Analysis (HGA) analysis for a variety of containers. It’s debut was at this year’s Pack Expo Las Vegas.
LASERCUBE provides a non-destructive, non-invasive laser-based inspection solution for leak detection and container closure integrity testing (CCIT) by measuring the headspace level of gases, such as oxygen and carbon dioxide, as well as monitoring moisture levels.

HGA is suited for accurate investigation of translucent containers and pharmaceutical finished containers, as well as headspace conditions for products packaged under modified atmosphere and closure integrity, even where headspace is limited. The technology is designed to make Etalon effect negligible. It also removes any need for nitrogen purging during oxygen measuring.


The system features:

  • Low power consumption
  • Compact and lightweight design
  • Set-up via integrated PC or any wireless-connected touchscreen tablet or smartphone
  • Fully automated test cycle sequencing with manual loading and unloading of containers
  • Data storage and export (production, raw data, events, alarms)
  • Easy-to-use HMIU integrated functions
  • HMI real time display of statistics and raw data
  • Engineered to comply with FDA 21 CFR Part 11 and EU Annex 11

 

Please get in touch if you want to schedule a live demo or shoot us an email if you want to see it do the magic on a Virtual Conference.

Bonfiglioli will attend 2017 PDA Visual Inspection Forum

North Bethesda, MD, U.S.A., Oct 23 – Oct 24, 2017, tabletop # 209.

 


 

The 2017 Visual Inspection Forum, that take place in North Bethesda, MD, U.S.A. in the beautiful location of Bethesda North Marriott Hotel & Conference Center, continues to be an important element of the manufacturing process and the quality assurance of injectable products.

During the event case studies will be provided, new USP chapters<790> and <1790> will be explored, new developments in the field of visual inspection will be discussed, including contributions to a basic understanding of the sampling and inspection process, practical aspects of manual and automated methods, and the regulatory and compendial requirements that govern them.

The meeting will feature an exhibition where attendees can see the latest in commercial inspection hardware and discuss production needs; TASITEST Packaging Test & Inspection, the leading specialist on leak testing, measurement and inspection, that provides dedicated solutions as non destructive Container Closure Integrity TestingVisual Inspection and Headspace Gas Analysis for Laboratory and in-line packaging markets, will be present at tabletop # 209.

The complete and detailed agenda of the event and TASITEST tabletop can be consulted at PDA website https://www.pda.org/global-event-calendar/event-detail/2017-pda-visual-inspection-forum under “AGENDA”, “BROCHURE”,“FLOOR PLAN” sections.

Innovation Meets Sterile Manufacturing- Fedegari

 

Join us on October 19th at the new Berkshire Corporate Center, Lee (MA).
Don’t miss this opportunity to meet leading companies in the sterile manufacturing field and to learn through technical discussions and hands-on activities.

Learn more

Last spots available!

Don’t miss this workshop! A great opportunity to meet leading companies in the sterile manufacturing field and to learn through technical discussions and hands-on activities.

Book your spot here!

We look forward to meeting you in there!

Day 1 of Pack Expo

As day One of this year’s PACK EXPO Las Vegas comes to an end, we’d like to thank you all for connecting with us and meeting with our Project Engineer and Sales Rep Joe Skorcz.

If there is something that you wanted to ask or add to your meeting and didn’t had the chance or forgot to mention it, feel free to contact our office and discuss what you have on mind with the rest of Life Scientific, Inc. team.

We can bring you up to speed on the latest trends, technologies, innovations and insights to help your operations. We can assist you and help better understand how our equipment operates and why it could be the best solution for your facility.

Still not convinced?

Stop by our manufacturer’s booths at Pack Expo where you will see cutting edge technologies in action, investigate new solutions and leverage the education they can provide.

Please take note of our manufacturer’s locations

 

Bahnson Environmental Specialties
North Hall – Booth #304

The highest demanded Reach-In Environmental and Photostability Chambers in Vaccine storage.

 

 

 

 

 

 

 

Newman Labeling Systems Inc.
North Hall – Booth #437

Newman’s newly appointed Managing Director Shaun Baker will be in attendance.  Newman Labeling Booth is offering a Special Pack Expo 18% discount.

 

 

 

 

 

 

TASI Test Group
North Hall – Booth #209

TasiTest, leading specialist of packaging leak detection solutions, will showcase its latest product developments at Pack Expo Las Vegas on booth 209 in the North Hall.

 

 

 

 

 

Cozzoli Machine Company
Central Hall – Booth #2006

Cozzoli is exhibiting the FSV50 Mini Monoblock, the FPS2-SS Ampule Fill & Seal Machine. They’ll spotlight their tabletop equipment.

 

 

BONFIG LASERCUBE Live Demos

Overview

The BONFIG LASERCUBE from Bonfiglioli Engineering is a bench top system for performing Headspace Gas Analysis (HGA) analysis of sterile pharmaceutical containers, such as cartridges, ampoules and pre-filled syringes.

It provides a non-destructive, non-invasive laser-based inspection solution for leak detection and container closure integrity testing (CCIT) by measuring the headspace level of gases, such as oxygen and carbon dioxide, as well as monitoring moisture levels.

Design & Features

BONFIG LASERCUBE uses an inspection method created to meet specific customer requirements for s user-friendly solution to needs for ampoule, cartridge and pre-filled syringe leak testing and HGA.

The non-destructive, non-invasive laser-based inspection system is designed to measure the headspace levels of gases, such as oxygen and carbon dioxide, as well as monitoring moisture levels.

HGA is an ideal solution for accurate investigation of translucent containers and pharmaceutical finished containers, as well as headspace conditions for products packaged under modified atmosphere and closure integrity.

The BONFIG LASERCUBE measuring system ensures extreme stability and accuracy in inspection even where headspace is limited.

This is a compact and lightweight system that is easy to use and set up via integrated PC or any wireless-connected touchscreen tablet or smartphone.

The technology is designed to make Etalon effect negligible. It also removes any need for nitrogen purging during oxygen measuring.

User benefits:

BONFIG LASERCUBE is designed to meet the needs of Quality Assurance, Production, Maintenance, Production or Laboratory analysts in pharmaceutical companies producing sterile products. The solution delivers an impressive set of user benefits:

  • Non-invasive and non-intrusive inspection method
  • Near elimination of Etalon effect
  • Fast, reliable and repeatable results
  • Nitrogen purging not required during oxygen measuring
  • Compact and durable design
  • Maintenance-free
  • Quick changeovers
  • Cost-effective solution with low power consumption
  • Fully automated test cycle sequencing with manual loading and unloading of containers
  • Data can be stored and exported (production, raw data, events, alarms)
  • Enhanced easy-to-use HMIU integrated functions
  • HMI real time display of statistics and raw data
  • Validation package guarantees complete and efficient regulatory compliance

 

All TASITEST computerized systems are engineered to comply with FDA 21 CFR Part 11 and EU Annex 11.

Live demonstrations

Bonfiglioli Engineering formally launched the BONFIG LASERCUBE at the Interpack 2017 exhibition in Dusseldorf.

The Laser Cube debut in USA is going to be at this year’s Pack Expo Las Vegas at TasiTest booth N-209 therefore we invite anyone interested in the system to attend live demonstrations at the TASITEST’s booth.

Demonstrations will take place every morning and afternoon on each day of the show, if you want to get more up close and personal with this equipment schedule a demo at your facility at time that is most convenient for you.

 

 

Reservations for demonstrations can be made by emailing or calling Life Scientific, Inc. at:

MaryBeth:

Email: marybeth@lsi1.com                                               Phone: +1 800-829-5741

Piero:

Email: ppolastri@tasitest.com                          Phone: +1 414-335-5973