Solutions

DIR's Induction Integrity Verification Solutions wins ACHEMA 2015 Innovation Award
Read more

I2VS

Because sampling isn’t enough.

DIR Technologies: SFM
Read more

SFM

Because one leak is too many.

I2VS

Induction Integrity Verification System

What is it?

DIR’s I2VS is the first in industry 100% in-line inspection system for induction sealed bottles and jars that is non-intrusive and does not result in production slowdown. A quantum leap from sampling to monitoring every single package – the system goes a step further to provide process control by indicating not only if an issue occurs, but what caused it, giving the opportunity to amend in real time.

How does it work?

The I2VS combines high end thermal imaging normally used in the defense industry with sophisticated analysis algorithms and proprietary IP to provide real time integrity monitoring of every single bottle on the packaging line – at the speed of the machine throughput. Inspection is “hands off”, non-invasive and non-destructive. Nothing is projected at the product; the I2VS reads and analyzes the inherent heat signature of the cap’s liner (which is amplified directly after induction). The I2VS is compatible with most bottle and caps sizes and types and can be easily integrated in to almost any packaging line.

Trend analysis example

Bottles rejected (red), problem analyzed, torquer fixed and rejections returned to acceptable levels

row2

Why do I need I2VS?

  • Ultimate quality assurance of primary packaging induction sealing – 100% inspection
  • Unprecedented process control – Discover and fix potential problems in real time
  • Fast – No slow-down of the packaging line
  • Tamper evidence integrity verification
  • Detects when the cap is not fully closed, indicating that the child resistant mechanism will not be effective
  • Reduce customer complaints
  • Designed for simplicity – Sophisticated technology engineered to minimize human error, easy GUI, simple user interface
  • Non-interfering, non-degrading inspection – integrity analysis is done through the cap
  • ROI – Cuts costs inherent in sampling methods, minimizes waste (time, work-backs, materials and labor)
  • Reports enable statistical process control of the induction sealing process over time
  • Brand integrity – Assurance that brand standards are upheld on the packaging line

SFM

Sachet Full Monitoring

What is it?

DIR’s SFM is the first in industry 100% in-line inspection system that provides: 1. Full monitoring of sachet sealing integrity and 2. Content monitoring of fill levels including identifying an empty or incorrectly filled sachet. The SFM offers a quantum leap from sampling to monitoring every single sachet, enabling issues to be discovered and fixed in real time. The SFM is non-intrusive and does not result in production slowdown.

How does it work?

The SFM combines thermal imaging and sophisticated analysis algorithms to provide real time integrity inspection of every single sachet on the packaging line – at the speed of the machine throughput. Inspection is “hands off”, non-invasive and non-destructive. Nothing is projected at the sachet; the SFM reads and analyzes the inherent heat signature of the sachet seal itself (which is amplified directly after heat sealing). The SFM can monitor most sachet laminates and most contents: powder, gel, liquids, cream etc. Sachet line length or width is not an SFM limitation. The SFM can be acquired as an integrated option in Mediseal sachet machines.

Why do I need SFM?

  • Quality assurance of sachet sealing – 100% inspection
  • Content monitoring of fill levels
  • Stop leaking sachets before they go to market
  • Protect product shelf life, avoid potential contamination
  • Discover and fix potential problems in real time
  • Fast – no slow-down of the packaging line
  • Designed for simplicity – sophisticated technology engineered to minimize human error, easy GUI, simple user interface
  • Non-interfering, non-degrading inspection – integrity analysis is “hands off”, no contact with the sachet
  • ROI – cuts costs inherent in sampling methods, minimizes waste (time, work-backs, materials and labor)
  • Reports enable statistical process control of the sachet sealing process
  • Brand integrity – assurance that brand standards are upheld on the packaging line

Research for the future

DIR R&D is directed at the uncharted waters of high-end thermal imaging solutions for the pharmaceutical industry with the goal of creating innovative, new ways of leveraging premium technology to help protect public health and safety.

Technology

Thermal imaging

All objects have a certain temperature and emit waves of energy, invisible to the naked eye, called infrared radiation (IR). Generally speaking hot objects emit more energy than cold objects. A thermal imager creates a viewable image from the IR waves, showing a “heat picture” of a scene.

Thermal imaging for inspection

Thermal imaging is used for inspection in a variety of industries due to the ability to detect what would otherwise be invisible, in a non-intrusive, non-destructive manner.

Thermal imaging technology was originally developed for the defense industry and is used for military and security applications. Common applications of thermal imaging include non-intrusive inspection of plumbing, electrical systems and insulation. Thermal imaging is also used by firefighters to find, for example, trapped people in smoke-filled buildings, as well as in commercial aviation, ensuring precision approaches and safe landings in reduced visibility conditions such as night, thick fog, smog, heavy rain and snow.

Dynamic Infra-Red for the pharmaceutical industry

Despite strict quality assurance guidelines and regulations, outdated packaging line inspection and quality control methods still permeate the pharmaceutical industry – making it ripe for the change DIR Technologies offers.

DIR Technologies harnesses a highly specialized part of the infra-red spectrum to create ultra-sophisticated, powerful infra-red cameras. Combined with high-speed image analysis, these enable DIR to provide unique and revolutionary monitoring and detection applications for the pharmaceutical industry and in particular, pharmaceutical primary packaging.

A quantum leap from sampling to monitoring every single package, DIR’s flagship solution, the I²VS is the first-in-industry, 100% in-line inspection system for induction sealed bottles that is non-intrusive and does not result in production slowdown. The system goes a step further, providing process control by indicating not only if an issue occurs, but what caused it, affording the opportunity to amend issues in real time. This process analytical technology (PAT) for the induction sealing process puts previously unavailable capabilities in the hands of pharmaceutical manufacturers and packaging suppliers.

Read more about DIR solutions

DIR Technologies - premium thermal imaging provides information that is not otherwise available, thus providing knowledge and capabilities that were not previously available DIR Technologies - this is what is visible with a regular camera or the human eye

Market Need

Sealed means safe

The USA Code of Federal Regulations stipulates that pharmaceutical primary packaging must be sealed to ensure the integrity (quality) of the drug product as well as the safety of the consumer.

CFR 211.94 b: “Container closure systems shall provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.”

And CFR 211.132: “A tamper-evident package is one having one or more indicators or barriers to entry which, if breached or missing, can reasonably be expected to provide visible evidence to consumers that tampering has occurred.”

Primary packaging is a vital element in the pharmaceutical manufacturing process and one that directly affects the drug being offered, its shelf-life and efficacy.

This raises the issue of testing; how can the manufacturer, dedicated to best quality, consumer safety and of course adhering to all the relevant guidelines and regulations, verify that 100% of packages coming off the production line are sealed to the standard that is needed for that particular product?

Sampling isn’t enough.

Sampling is the standard testing method today.

This method is limited in that it cannot detect discrete sealing discrepancies that can occur due to:

  • defects in the raw material – bottle or liner
  • problems in capping – false torque or crooked cap
  • problems with the induction sealer – alignment, field fluctuations etc.

Sampling cannot provide reliable insight in to the quality or stability of the sealing process.

A high degree of process understanding enables line operators to not only detect problems but to prevent them from occurring in the first place. This and the understanding that quality cannot be tested into products but should be built-in by design are at the core of the FDA’s PAT Initiative.

Sampling as a testing method is not chosen for its efficacy. It is the standard method used today simply because no better method was available. Until now.

100%, in-line inspection

DIR leverages premium thermal imaging combined with sophisticated analysis algorithms to enable 100% in-line inspection. This highly sensitive, completely passive technology offers a quantum leap in quality assurance and process control - the transition from sampling to inspection of every single package.

DIR’s Induction Integrity Verification System (I2VS) inspects each package, through the closed cap, at the speed of the machine throughput. There is no interference or degradation of the product – nothing is projected at the package, the I2VS reads analyzes the inherent signature of the cap’s liner (which is amplified directly after induction).

In addition, the source of any faulty seals (i.e. damaged bottle, liner, etc., or an issue in the sealing process such as torqueing or capping), is indicated in real time, which provides a high degree of process understanding and enables operators to not only fix problems immediately, but prevent them from occurring in the first place.

About DIR Technologies

Our Vision

Vision

DIR Technologies was born from the idea of utilizing high-end infra-red technology dynamically, with focus on the pharmaceutical industry.

Premium infra-red imaging or thermography is commonly used in the defense industry for night-vision, “smart” missiles and rockets etc.

DIR’s founders Eran Sinbar and Yoav Weinstein envisioned leveraging superior, battlefield proven technology to make the world a safer place. The pharmaceutical industry has a direct and deep impact on health and safety. Ironically, despite strict quality assurance guidelines and regulations, severely outdated inspection methods still permeate the pharmaceutical industry – making it ripe for the change DIR Technologies offers.

Dynamic solutions

DIR Technologies has developed first-in-industry thermography based inspection solutions for pharmaceutical quality assurance and process control.

The company introduced its first solutions in 2013 in the form of inspection and analysis systems for primary pharmaceutical packaging. DIR solutions offer a quantum leap from  commonly used methods of sampling by providing 100% in-line, non-intrusive inspection that does not result in production slowdown.

DIR’s Induction Integrity Verification System, or the I2VS draws on proprietary, patent pending technology to inspect the integrity of induction sealed bottles. The I2VS monitors the induction process itself, providing insight on its stability and empowering the operator with the ability to detect and amend issues in real-time.

The I2VS checks 100% of packages without reducing line speeds. Thermal imaging not only allows inspection to be done through the closed cap without damaging or degrading the product, but also allows for the collection of precision data regarding overall process quality.  The unit’s sophisticated algorithms enable swift, in-line analysis of data, an immediate accept/reject of bottles and, when a faulty bottle is detected, an indication of why the problem occurred.

Similarly the SFM, DIR’s Sachet Full Monitoring system, draws on thermal imaging to monitor sachet sealing integrity and content levels. The SFM can monitor most laminated sachets and most contents: powder, gel, liquids, cream etc. Sachet line length or width is not an SFM limitation.

Primary packaging sealing integrity is critical in ensuring product viability and shelf life. Leaking sachets that previously went undiscovered can now be stopped before they reach the market. Contamination can be prevented, protecting the health and safety of end users. DIR provides unprecedented insight on the sealing process of both induction sealed bottles and sachets, putting previously unattainable options and control in the hands of line managers.

Dynamic people

The DIR team was assembled with excellence in mind – each member was carefully chosen, not only for expertise, in his or her own field but also for dynamic personalities and collective synergy. Innovation and daring to think differently combined with deep professional knowledge is what sets the DIR team apart.

The team includes some of the premier thermography oriented minds in the world. Originally, most of DIR’s top executives served in key positions at SemiConductor Devices SCD, one of the world’s largest manufacturers of advanced infrared sensors – providing DIR with a solid technological basis and the ability to transition infra-red applications to the pharmaceutical world.

 

DIR Technologies: Make a change

Service & Support

Service & Support office hours:
08:00-22:00 UTC+02:00

Toll free number from US & Canada:
1-866-5181793

Toll free number from Europe:
1-800-65181793

Contact Us

DIR Technologies

Matam Towers 3, 6F
P.O.Box 15129, Haifa, Israel 3190501

Tel: +972 (4) 850-1190

Fax: +972 (4) 850-1192

Email: info@dir-technologies.com

DIR representatives around the world

NORTH AMERICA

BTS INTERNATIONAL, LLC
Robert R. Hartwig, P.E.
Franklin Lakes, NJ, USA
Tel: +1 (201) 961-4740
Email: bhartwig@bts-intl.com

FRANCE

ADMC
1 rue de la belette
91410 Dourdan, France
Tel: +33 (1) 6081-0423
Email: jf.meriot@admcontrole.fr

SOUTH EAST ASIA

PT ASIA Co., Ltd.
998 Moo 3, Samrong Nua,
Muang, Samutprakarn 10270,
Thailand
Tel: +66 (0)2 759-0717
Fax: +66 (0)2 759-3569
Email: Kiran@ptasia.biz

ITALY

FKV, SRL.
Largo delle Industrie 10
24020 Torre Boldone (BG), Italy
Tel: +39 (035) 369-0211
Fax: +39 (035) 369-0399
Email: info@fkv.it

INDIA

ACE Technologies & Packaging Systems Pvt., Ltd.
223/242, Blue Rose Ind. Premises C.S. Ltd.,
Western Express Highway
Borivali (E), Mumbai – 400066
Tel: +91 (22) 2870-0281
Fax: +91 (22) 2870-4108
Email: acetechnologies@vsnl.net