Newman Easiplice 470 Labeling System

An aspect of self-adhesive labeling which often gives cause for concern is the loss of production time incurred by label replenishment. Such losses become increasingly significant as machine speeds increase – more frequent reel change-overs result in more production downtime.

The Easisplice overcomes this concern by enabling reel change-overs to take place with no interruption to the supply of labels to the label head.

The Easisplice is supplied as a free-standing unit complete with an angled twisting bracket.


The Easisplice unit holds two reels of labels – one acts as the current label supply while the other is positioned to facilitate rapid splicing. A microprocessor control unit working in conjunction with photoelectric cells ensures that a constant buffer stock of labels is available in the buffer bin to the labeling machine.

As the current label reel nears its end, a flashing beacon alerts the operator, who triggers the reel to fully dispense into the buffer bin.

The end of the label reel is automatically detected on the splicing table, signaling the Easisplice to stop. The second reel is manually spliced whilst labeling continues using the labels in the buffer bin. Once the splice is made a reset button is activated and uninterrupted labeling continues

Contact LSI today to receive more information, technical specs, and the latest pricing on these machines.

WUXI BIOLOGICS chooses Fedegari for its largest bio-manufacturing facility in Ireland

WuXi Biologics, Chinese world leader in the production of biotech pharmaceuticals, has chosen Fedegari Group to supply 15 high-performance process machines – GMP washers and autoclaves – for its new production site in Ireland.

The new headquarters to be inaugurated in Dundalk will receive investments of 325 MEUR and the construction will provide the employment of 700 people with the creation of 600 new jobs by 2024. The manufacturing project in a 26-hectare campus, the company’s first site outside of China, is supported by the Irish Government through IDA Ireland.

Wuxi’s state-of-the-art facility will employ multiple single-use bioreactors for commercial biomanufacturing and is designed to be able to run continuous bioprocessing, a next generation manufacturing technology to be first implemented globally in this campus. A total of 48,000 l fed-batch and 6,000 l perfusion bioreactor capacity will be installed, representing the world’s largest facility using single-use bioreactors.

“The global bio/pharma market is changing, and we are experiencing an ever-growing interest in our business model. The pre-requisite for introducing more cost-effective and reliable drug manufacturing solutions is a strong technical partnership between end-users and, equipment suppliers. Without a rock-solid relationship of trust, the end-users will not dare to invest in unconventional solutions. However, this relationship will not develop out of bombastic statements on a website rather is the consequence of a tested technical relationship”, said Giuseppe Fedegari, President of the group.

The collaboration between Fedegari and WuXi began in China in 2018. The new project in Ireland strengthens the relationship with the supply of 8 high- performance sterilizers and 7 eco-steam washers for a value of about 4 MEUR.

This agreement consolidates Fedegari presence in the Asian market, which corresponds to 30% of the company revenues.

If you want to learn more about the Fedegari product line contact our office today and discuss your upcoming project with our representatives.

Could The Coronavirus be a result of a Bio-Safety Cabinet accident?

A recent article by the Washington Post titled State Department cables warned of safety issues at Wuhan lab studying bat coronaviruses gave the public a better idea of how the World pandemic may have started. In relation with that, Aseptic Enclosures have explored the risks of operating lab processes at the safety levels as those at the WIV laboratory. Although the argument and main focus of that article is on exposure to hazardous chemicals in pharmaceutical settings, but the information cited is applicable to all Bio-Safety Cabinet lab operations that are considered to be “safe” by regulation.

Feel free to browse through the article that compares Hazardous operations within Bio-Safety Cabinet and Aseptic Isolation settings and make a decision on which areas do you feel have more exposure risk.

Two years before the novel coronavirus pandemic upended the world, U.S. Embassy officials visited a Chinese research facility in the city of Wuhan several times and sent two official warnings back to Washington about inadequate safety at the lab, which was conducting risky studies on coronaviruses from bats. The cables have fueled discussions inside the U.S. government about whether this or another Wuhan lab was the source of the virus — even though conclusive proof has yet to emerge.

The cables warned about safety and management weaknesses at the WIV lab and proposed more attention and help. The first cable, which I obtained, also warns that the lab’s work on bat coronaviruses and their potential human transmission represented a risk of a new SARS-like pandemic.

“During interactions with scientists at the WIV laboratory, they noted the new lab has a serious shortage of appropriately trained technicians and investigators needed to safely operate this high-containment laboratory,” states the Jan. 19, 2018, cable, which was drafted by two officials from the embassy’s environment, science and health sections who met with the WIV scientists. (The State Department declined to comment on this and other details of the story.)

There are similar concerns about the nearby Wuhan Center for Disease Control and Prevention lab, which operates at biosecurity level 2, a level significantly less secure than the level-4 standard claimed by the Wuhan Insititute of Virology lab, Xiao said. Inside the Trump administration, many national security officials have long suspected either the WIV or the Wuhan Center for Disease Control and Prevention lab was the source of the novel coronavirus outbreak. According to the New York Times, the intelligence community has provided no evidence to confirm this. But one senior administration official told me that the cables provide one more piece of evidence to support the possibility that the pandemic is the result of a lab accident in Wuhan.

Every day new documentation and evidence appear to the surface proving that the Coronavirus came out of the lab. Probably, some researchers got exposed while handling the materials and samples in a Bio-Safety Cabinet.

It is highly likely that all of this would not have happened if that lab technician was working in a CACI.

Newman Labelling CTE450

The CTE450 is a fully automatic labelling system that applies a wide range of self-adhesive tamper-evident labels, anti-counterfeit and hologram labels to erected cartons.

It has been designed primarily for the pharmaceutical industry where high levels of production efficiency will be a prerequisite for the introduction of Track and Trace systems onto existing packaging lines compatible with the EU Falsified Medicines Directive and other global Serialisation initiatives.

The CTE450 is also highly energy-efficient, compact and incorporates full Newman ‘validation-friendly’ specifications.

At the infeed, cartons are separated, held between top and bottom belts, past the Print and Inspect station where Serialised codes can be printed and then verified by a Vision system. Cartons are then transported past two stepper motor-driven label stations. Labels are dispensed on to the overhanging vertical faces of the carton and applied with a roller. Airplane and reverse tuck formats can be accommodated. Cartons proceed to the sensing station where sensors detect label presence prior to wipe down. Both labels must be present for a carton to be accepted; if not, it is ejected into a secure reject area


  • Track and Trace Serialisation capability
  • Compact GMP Design with stainless steel finish
  • In-Process Control
  • “Positive accept” security system
  • Automatic critical device checking
  • Twin reject bins
  • Reject verification
  • Product and reject the counter package
  • Validation Documentation Package
  • Low energy consumption

To request further information or the latest pricing give us a call at: 800-829-5741

Headspace Gas Analysis: What’s on the Shelf?

Many injectable drugs are sealed into containers (typically glass vials or ampoules) after processing, in protective atmospheres to avoid contact with air that can damage quality & effectiveness. Nobody would like to open a yogurt jar and find fungus or buy medicine and find it has lost its effectiveness due to oxidation.

Here we are identifying two main impacts: Business Impact and GMP (Good Manufacturing Practice) Impact. In the first case, the company can lose business, in the second, it could cause serious illness to people. Different Container Closure Integrity Testing (CCIT) methods can be put in place to avoid the above: Vacuum Decay, Pressure Decay, Force Decay, Lid Deflection, Spark Test and last but not the least Headspace Gas Analysis (HGA).

Pharmaceutical Companies are required to protect their products not only with proper and safe enclosures, but they must also fill the space that surrounds the product (i.e. headspace), with some particular gases (e.g. Nitrogen, Carbon Dioxide) or simply maintain a high level of vacuum inside the enclosure, to avoid contact with oxygen or moisture.

At this point dear reader, I hope you have understood why it is so important to know what’s happening inside the headspace of your container. Headspace Gas Analysis plays an important role among the CCITs. Let’s add some more details.

Two different methods can be used to inspect headspace: destructive and non-destructive methods. In the destructive method, measurement of gas percentage present inside closed package requires the necessity to bring part of its internal atmosphere in contact with a proper sensor (e.g. chemical cell or zirconium oxide for oxygen) to be able to produce electricity proportionally to the gas concentration or use optical fluorescence technologies in case of oxygen detection. Both inspection methods result in package destruction.

Tunable Diode Laser Absorption Spectroscopy (TDLAS) is a non-destructive method, able to measure the concentration of a certain gas in closed container, with a sufficient headspace size to pass through with a laser beam with fairly good transparency to laser light: glass and plastic containers can be inspected as well if these conditions are satisfied. TDLAS is a technology based on laser absorption spectroscopy, wherein the wavelength diode laser is tuned over the absorption line of the gas under test (760 nm for Oxygen, 1854 nm for Moisture, 2000 nm for Carbon Dioxide) and the intensity of the transmitted radiation is measured.

More the gas molecules are present in the head space, less the energy will arrive at the photodiode used to convert light into an electrical signal. The transmitted intensity can be related to the gas concentration by the Beer-Lambert law. It is possible to obtain information related to the gas under test measuring Area and Width of the Absorption Curve.

However, these measurements are unitless, so a Calibration Procedure is necessary to correlate these values to Gas Concentration (%) or Total Pressure (mbarA).

Calibration Procedure is strictly related to the Standards concept. It is possible to apply techniques of modulation in high frequency to further improve the signal-to-noise ratio, ensuring the detection of small variations of signals in front of a wider operating range: WMS (Wavelength Modulation Spectroscopy) and FMS (Frequency Modulation Spectroscopy) are the most common types of modulation techniques. FMS has a higher modulation frequency (some MHz) than WMS (some KHz); a lower laser residual noise is its main advantage; however, the detectable minimum quantity of gas is less dependent on laser residual noise than Etalon Effect for instance.

Furthermore, working at such high frequencies has another drawback: we need to use analog electronic components instead of digital ones thereby renouncing great advantages coming from them.

Now that we have more knowledge of this technology, we could be interested to understand how to take advantage from a non-destructive method.

You can focus on the following comparisons between the standard destructive method and the non-destructive HGA method to draw your own conclusions:

• Standard Methods to measure gas concentration or pressure value are destructive.

The packages can’t be recovered even if we have a conforming test… HGA is a non-destructive measurement method; packages can be recovered after confirming tests.

More valuable the product, more the item is important;

• Standard Methods are slow; they can’t guarantee 100% check of the whole production… HGA is very fast and it can be placed into an in-line process to test 100% of the production.

It is more expensive, but the return of investment covers the overall expenses;

• Standard Methods of Leak Detection don’t find non-conforming packages due to process anomalies if they are properly sealed… HGA finds non-conforming packages even if they are properly sealed; it measures the gas partial pressure in the headspace.

It is important to remember however, that HGA is not a leak detector if the quarantine period is not part of the production process.

I hope you have found some interesting food for thought about these intriguing arguments.

VACUUM TECH by Vetromeccanica

Vacuum Tech is the right solution to convey lightweight, unstable, empty containers.


The suction unit is installed beside the conveyor that presents a pierced chain made of a plastic material. Through this chain, the air is drawn from the base of the container.
The power of the electric motor ranges from 5,5 to 7,5 kW according to the type of container to be conveyed.

To optimize and control the vacuum system functioning there is a pressure control unit for each suction unit.


Contact us for more information: 800-829-5741

Bonfiglioli Engineering Inspection Post

As you already know by now, the B.E.Inspection Post (quarterly journal by BONFIGLIOLI ENGINEERING), contains a wide range of topics like technology insights, what’s happening inside B.E., interviews with team members, contributions by our stakeholders, book suggestions, upcoming events, case studies and lots more. It is the people’s magazine and the articles have been written by diverse team members of Bonfiglioli Engineering.

In the third edition, we focus on Lean Manufacturing and how Bonfiglioli engineering has embraced this concept for optimal processes and results, an insight into our Product Sheets, an article on the History of Aerosols, the new website and an interview with our colleague in the company.

The B.E.Inspection Post represents our company and each one of us. This is our way of being closer to you, our Clients, Employees, Partners, Suppliers and sharing a part of ourselves with you.

We sincerely hope you enjoy reading it.

Do send us your feedback.

Click on the cover to get your copy NOW!

Inline Fill to Level Machinery

The Inline Fill-To-Level Models are moderate speed fillers, ruggedly designed, yet precision built for long, trouble-free liquid filling operation. Each model features a fill-to-level design with filling accuracy maintained to within +/- 1/16 of an inch of targeted fill level. The inline series includes three easy to operate models – manual, semi-automatic and fully automatic, with machine cycle speed up to 8 cycles per minute. Either gravity, pressure, vacuum, or combination filling systems can be utilized. A diverse range of products, including cosmetics, chemicals, food and beverages can be filled on these versatile machines.

Suggested for use as either a lab model or as a small batch production line. The operator simply slides containers onto a stainless steel slide track to an adjustable stop point. The nozzles are now centered above the container openings. The operator lowers the spout bar, which brings the nozzles down into the containers and seals the openings. At this point, the filling cycle begins. When the operator sees product discharging from the overflow nozzle hose, the cycle is complete. The head is then raised and the container stop is manually released to discharge the containers.


• Configured with 2 to 12 Filling Nozzles

• 12 Gallon Stainless Steel Supply Tank

• Programmable Logic Controller (IFLA)

• Fully Automatic Operation (IFLA)

• Type 316 Stainless Steel Wetted Contact Parts

• Type 316 Stainless Steel Filling Nozzles

• Fully Wired 220 Volt, 3 Phase, 60 Cycles

• Accuracy to +\- 1/16 of 1 inch

• Automatic Overflow (IFLA)

• Pneumatic Operation of Fill Head

• Left to Right Direction

• PVC Flexible Tubing


• Quick Change Nozzles

• 25 Gallon Stainless Steel Supply Tank

• Type 304/316 Stainless Steel Frame

• Stainless Steel Conveyor Chain

• PVC, Teflon, Hastelloy or Titanium

• Nozzles and Contact Parts

• NEMA 7 Explosion Proof Electricals

• Positive Displacement Pumps

• Special Tubing for Product Compatibility

• Pneumatic or Mechanical Centering

• Right to Left Direction

• Flush in Place System

For further information contact us at: 800-829-5741.


HEADSPACE GAS ANALYSIS is a laser-based, non-destructive and fully automatic inspection method for sealed packages. It allows for measuring oxygen concentration, carbon dioxide, residual moisture content and absolute pressure value. Its purpose is to verify the headspace conditions and their maintenance to confirm stability and sterility in filled and finished parenteral packages.

Monitoring the maintenance of container headspace conditions is needed for sterile drugs such as oxygen sensitive liquid products and lyophilized or powdered products; any modification in the headspace pressure, moisture or oxygen level may result in the degradation of the active drug, as well as in the reduction of drug potency and product shelf life. Traditional headspace analysis methods include testing by means of a probe, generally performed on samples at regular intervals during the production cycle: a destructive, time consuming and unrepeatable procedure, which prompts the issue of disposing of destroyed products and leaves with no timely feedback on the filling process. Each time out of specification conditions are detected on a sample container, the entire batch is to be rejected, making it most difficult to assess if it is random package closure integrity failure or systematic process unwanted deviation. BONFIG, instead, offers a non-destructive, more deterministic and reliable procedure.

For oxygen detection, the laser beam is reflected by a golden mirror towards the receiver allowing a double passage of the headspace target. Double Path system significantly increases the signal strength and makes Etalon Effect negligible by means of a small tilt.

The laser system performance is practically insensitive to environmental factors such as oxygen presence thanks to its electronic design. Therefore, when performing headspace level analysis, there is no need for purging the surroundings of the container under inspection with nitrogen.

Since height & width of laser absorption signals are measured and compared to preset values (Standard Containers) during each cycle, a reference pack is not required in operation. If the measured parameters are not within acceptable ranges, the equipment automatically signals it.

Specific requirements for sterile drugs packaged under full or partial vacuum are covered by EU GMP Annex 1 Manufacture of Sterile Medicinal Products, section 123: “Containers sealed under vacuum should be tested for maintenance of that vacuum after an appropriate, pre-determined period”. The testing method conforms to provisions expressed in United State Pharmacopeia, USP General Chapter <1207> “Package Integrity Evaluation – Sterile Products” (USP 39-NF34):

Laser-Based Gas Analysis is listed among the Deterministic Leak Test Technologies. Validations and qualifications are easy to perform by means of advanced protocols and documentation.

A Tunable Diode Laser Absorption Spectroscopy (TDLAS) based sensor is the core of the inspection system installed in our unit, a spectroscopic method allowing the detection and quantification of gaseous components concentration. The principle underlying the TDLAS measurement is based on the Beer-Lambert Law, stating that light transmitted through a given sample at a particular wavelength is a function of the concentration of the substance that is absorbing the incident light.

A diode laser beam, at a wavelength optimized for the measurement of a particular gas species, is transmitted through the headspace region of the container and received by a detector after passing through the container itself.

Oxygen level monitoring is obtained with a light source tuning at a wavelength of 760 nm, while carbon dioxide at 2000 nm and wavelength of 1400 nm is employed to obtain measurements of residual moisture level and absolute pressure.

The inspection time of BONFIG systems is shorter compared to the ones currently available on the market: this results in a better test performance either more accurate or faster.

Please contact our representatives to learn more about our current Headspace Gas Analysis solutions by calling 800-829-5741.

PK series Inline Container Closure Integrity Test Machines

A complete range of products that covers all nominal production throughput/ speed of production lines.

Each Machine is designed for Non-Invasive, Non-Destructive Integrity Testing of diverse type of Pharmaceutical Containers and Contents. It is conceived for 100% in-line testing at high production speed. Testing is fast, reliable and repeatable, giving consistent results and allowing for full batch control without altering the container or content features.

Vacuum Decay or Pressure Decay Methods allow to reach full compliance with current GMP international regulations.

High class mechanical design and automation solutions fit for the purpose to perform, ease service and avoid downtime.

Equipment has full capability to be integrated in Industry 4.0 environment with Electronic Batch Record management or Manufacturing Execution Systems.


With the same machine, various tests are available; in terms of contents: liquid, lyo and powder and in terms of containers: wide range of sizes. High quality handling system, comprising State of the art electronic actuators and motor inverters, as well as high class mechanical design allow high machine adaptability to line output variations. Optimal testing results are achieved at nominal speed and also in case of speed reductions and increases.


High machine installation flexibility, by means of rotating tables or other systems like tray loading, it is possible to install the machine in-line, off-line or next to the production line.


Production, test and alarms reports are printable either local or network printer. Testing and production data are downloadable on USB driver and printable either local or network printer.


Statistical Process Control is conceived to give full support to the quality system, maintenance and process control staff. It allows to improve control ability and to have a constant evaluation of the manufacturing processes, keeping track and analyzing the collected data on different time frames. This brings to reduced deviations and basically helps to improve the yield. Features of Statistical Process Control are: – Trend analysis – Alarm Statistics – Histogram Graphs – Run Charts (X and R) Giving statistical representation of measurement acquisitions, it is possible to calculate significant process parameters (Avg,, Cp,Cpk). From another perspective, it also saves the historical data for comparison, gives quick access to most frequent failures both of the GMP critical, business and safety ones. Pareto diagrams representations allow to highlight the most relevant failure modes, calculating Statistical parameters (i.e.: MTBF – Mean Time Between Failure and MTTR – Mean Time To Repair).


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”

FDA 21 CFR Part 11 and EU Annex 11


The system generates the following logfiles: Production report, Tests report, Events report, Alarms report. Complete and accurate historical data copies are available through the use of a viewer utility on Report graphical pages (accessible as read-only) and can be downloaded. Electronic data which are stored into the System cannot be deleted or changed by any user. Electronic signature is available for verification and authorization of most critical process steps.

HMI Operator interfacing is featured by a SCADA System made up of interactive graphical pages allowing to: – Manage Electronic Records, Operators accounts and System accesses – Report and record Operator critical actions, process activities, anomaly conditions (Audit Trail) – Control Testing Process and access to online Troubleshooting – Set Machine critical parameters (Recipes, Operators, Configuration) HMI Real Time display of Leak Testing Cycle diagram.

GAMP 5 COMPLIANCE Equipment computerized system is designed according to ISPE GAMP 5 guidelines.


Machine Leak Testing Measurement System follows the approved industry standard “ASTM F2338-09”: “Standard Test Method for Non-Destructive Detection of Leaks in Packages”. 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 (Reference: Federal Register Notice FR Notice (list #014) [Docket No. 2004N-0226].


Autotest function has the aim to verify the measurement system capability to detect leaking Containers simulating a Calibrated Leak. This function is useful and applicable during qualification stages as well as during usual production cycle, to automatically confirm proper functioning and behavior of each testing chamber.


Relative Transducer Functionality Algorithm Checking every Relative Transducer both for incorrect Atmospheric Pressure Reading and for overpressure. The monitoring operation is executed in continuous during run-time.


This system automatically dries each Testing Chamber which might have been contaminated by liquid or moisture left by leaking Containers. To avoid the possibility of producing false rejects, it is necessary that every potentially contaminated Testing Chamber is brought back to its optimal state of operation before this is allowed to test other Containers. With A.D.S. enabled, Containers are not fed into the Testing Chamber to be dried but passed on to the next available one. As a result, this particular Chamber will perform an empty cycle during which a continuous vacuum dries it. Whilst under vacuum, any residue will be evaporated, therefore drying the Testing Chamber.


This system has the function to avoid variations in Pressure readings coming from the Relative Transducer by means of compensating any changes due to atmospheric pressure fluctuations.


Support to customer’s URS development for specific application to reach, considering a common definition (customer and supplier), the best possible solution.


Autodiagnostics automatically verifies the optimal working condition of: Pressure and Exhaust Electrovalves, Relative Pressure Transducers, Testing Chamber (in terms of airtightness). Autodiagnostics is automatically enabled at Machine Start-Up and can also be manually activated while Machine is in production phase, pressing a dedicated button on the HMI. Container feeding to the Central Carousel is mechanically blocked during the Autodiagnostics execution.


Machine Qualification and Validation complies with requirements stated in EU Annex 15. Validation Package guarantees complete and efficient regulatory compliance. Standard Validation Package includes: Project Quality Plan, Functional Design Specifications, Mechanical/  Hardware / Software Specifications, FAT /SAT, IQ and OQ. Moreover, following documents are available for delivery: Performance Specifications, Performance Qualification, Design Qualification, 21 CFR Part 11 Compliance Table, Traceability Matrix to supplied URS.

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