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.

VACUUM TECH – FEATURES AND ADVANTAGES

– SUCTION UNIT AND VACUUM TRANSFER SYSTEM 
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.

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

– ALMOST NO MAINTENANCE NEED

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.

FEATURES

• 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

OPTIONS

• 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.

What is HEADSPACE GAS ANALYSIS

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.

MULTIPLE FORMAT, CONTENT TYPE AND SIZES MACHINE

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 FLEXIBILITY INSTALLATION

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.

REPORTS & DATA MANAGEMENT

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

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, std.dev., 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).

REGULATORY COMPLIANCE

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

DATA INTEGRITY

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.

TEST METHOD

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

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 FUNCTION

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.

AUTOMATIC DRYING SYSTEM

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.

BAROMETRIC COMPENSATION ALGORITHM

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.

TEMPLATE URS

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

AUTODIAGNOSTICS

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.

VALIDATION PACKAGE

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.

FIRST ISSUE ONLINE MAGAZINE BY BONFIGLIOLI ENGINEERING IS OUT

2019 is a new era for Bonfiglioli Engineering, with many new and exciting developments: expansion of the headquarters to a new and bigger site, structural reorganization and emphasis on customer care, focus on education and consultations for our clients, and other pleasant surprises planned for the year.

All this news and more will be collected & presented to all our stakeholders, every three months via the B.E. Inspection Post, the new informative journal from Bonfiglioli engineering. The B.E.Inspection Post contains a wide range of arguments like technology insights, what’s happening inside B.E., an interview 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. It is also your contributions that have made this magazine so rich. Thank you.

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.

Get your Copy from HERE

We sincerely hope you enjoy reading it.

Do send us your feedback.

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.

MULTIPLE FORMAT, CONTENT TYPE AND SIZES MACHINE

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 FLEXIBILITY INSTALLATION

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.

REPORTS & DATA MANAGEMENT

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

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, std.dev., 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).

REGULATORY COMPLIANCE

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

DATA INTEGRITY

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.

TEST METHOD

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

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 FUNCTION

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.

AUTOMATIC DRYING SYSTEM

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.

BAROMETRIC COMPENSATION ALGORITHM

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.

TEMPLATE URS

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

AUTODIAGNOSTICS

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.

VALIDATION PACKAGE

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.

Torqo 1600 Non-Destructive Cap Torque Tester available in the Trade In Program

The Torqo 1600 is a durable and reliable computerized cap torque analyzer which is setting a new standard for torque measurement throughout the packaging industry. With on-board microprocessors, it makes torque testing simple, accurate and affordable.

The Torqo 1600 is easy to use, easy to set up, easy to move and low maintenance!

Tooling is available for any threaded closure – including child resistant caps – and this compact unit delivers and stores precise results at the touch of a button.

The Torque product line has been providing accurate torque measurement readings for the past 50 years. The Torqo II+ system incorporates 15 years of factory floor proven technology, supplying customers with precision torque data to help improve the production as well as the packaging of the product.

Mesa Torque systems have become the standard in the beverage and pharmaceutical industries, consistently providing accurate and reliable torque level readings to help companies manage quality control.

• Compact Size

• Constant Speed Drive

• Simple Touch Screen Programming

• Calibratable in the Field • NIST Traceable Calibration

• Wide Operating Temperature Range

• Non-destructive Testing

• Full One-year Warranty

• USB Connectivity

• Ethernet Connectivity

• External Universal Power Supply

• LAN Connectivity

• RS-232 Port

Cap torque analyzers have been serving the torque industry for many years now. Many models done a tremendous job providing consistent, reliable data and providing However, most models were designed several years ago and contain many critical components that are now obsolete and unsupported. Mesa Laboratories, Inc. is offering an upgrade option for the Torqo 1590 to 1600. Call our office today and find out more.

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.

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