About Marko

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.

STERILITY TEST ISOLATOR By Fedegari

The FCTS Sterility Test Isolator has been designed for pharmaceutical samples taken from manufactured drug batches and meets all the requirements of the FDA, EMA, WHO and associated pharmacopoeia as well as all applicable EN standards and directives and international norms.

Suitable for:

  • Injectable liquids.
  • Ophthalmic ointments.
  • Sterile antibiotic powders.
  • Freeze-dried drugs.

When Fedegari started designing its first isolator, the goal was assuring customers the highest process reliability and repeatability possible.

FCTS sterility test isolator is equipped with the same solution that Fedegari has standardized in bio-decontamination pass-boxes, because the performances and the reliability of third party H2O2 vaporizers were not satisfactory. Moreover, with the FHPV there is no need of propietary consumables, reducing significantly operational costs.

This innovative design provides real time biocide concentration control (over traditional estimated calculations).

Through the H2O2 sensors and other devices, Thema4 assures that vapor concentration remains extremely constant (within ± 15 ppm) thus making process repeatability the logical consequence.

The FCTS sterility test isolator is compliant with the most stringent cGMP guidelines of Pharmacopeia. It has been classified as ISO 5 FDA and Class A EU GMP.

DESIGN AND TECHNICAL FEAUTURES

  • Working chamber has non-directional BA surface finishing (Ra ≤ 0.4 μm).
  • Air-tightness is 100% guaranteed by ultra-safe doors.
  • Equipped with an internal stainless steel trolley for material transfer from pass-box to working chamber assuring continuous loading of the isolator with materials.
  • Customizable internal storage and racks: can be designed according to customers’ needs.
  • FCTS is modular: customers can choose the positioning of the pass-box, the number of working chambers and gloves.

KEY BENEFITS

  • Significantly reduced operational costs: Non-proprietary consumables.
  • Reliability: Leak testing totally managed by Thema4.
  • Easy integration, throught Thema4, with other Fedegari machines and SCADA systems.
  • Cost-effectiveness: Drastically reduced validation time for cycle and load.
  • 100% air tightness: Silicon inflatable patented gasket on all doors.
  • Process control based on direct feedback, instead of estimations.
  • Grids and internal spaces that can be customized according to the load.
  • RTP Port for loading and unloading activities.

Learn more about the Fedegari String of products and solutions by contacting our offices at 800-829-5741

Life Scientific Inc Winners of Mesa’s Channel Partner Excellence Award!

Life Scientific, Inc. Winners of Mesa’s Channel Partner Excellence Award!

At Mesa Labs, Inc. (Mesa) our purpose is to protect the vulnerable. One way we do this is through partnering with companies that share this sentiment and rewarding them for all of the good work they put towards keeping things we hold dear safe. We took a look at the performance of each partner. We evaluated their highest achievements, the support they’ve shown towards customers throughout the year and determined who best exemplified excellence in overall performance and supporting our purpose in 2019. 

Mesa is pleased to announce the winners of our Channel Partner Excellence Award! 

“At Mesa, we strive to provide innovative, reliable monitoring and quality assurance products and services. Working with our channel partners ensures we deliver solutions and services of excellence to customers across the world.” – Gary Owens, CEO and President


Here are the 2019 winners and honorable mentions:

Torque

Winner: Life Scientific, Inc.

Life Scientific, Inc. protects the vulnerable by making sure their customers’ needs are heard while guiding them through the process of purchasing the correct equipment for their application. Additionally, Life Scientific understands that proper torque testing is essential to protect children from medications that are kept in bottles with loose lids. 

Honorable Mention: Select Packaging Automation

By strategically partnering with prominent manufacturers, Select Packaging Automation keeps your loved ones from harm by providing quality control solutions to pharma, beverage and other industries alike. They make it their goal to meet customer needs with reliable equipment and technical services that senses the risk before the problem begins. 


DataTrace®

Winner: Seika Corporation

Seika Corporation is a top partner for the DataTrace product line. They protect the vulnerable through providing quality control instrumentation to hospitals, labs, pharma manufacturers and other industries alike to make sure the food we eat every day is safe.

Honorable Mention: CiK Solutions

CiK Solutions is a company that thrives on customer satisfaction. They are always on the lookout for new customers who can benefit from DataTrace’s ability to monitor temperature, humidity and pressure permariters in critical environments to ensure the safety and efficacy of products we use on the day-to-day.


DryCal®

Winner: Quest Technology

Quest Technology provides their customers with effective industrial and environmental solutions to ensure that their employees and the public are safe. Through their representation of DryCal, Quest shows their support of environmental protection, workplace safety and ensuring defensible data.

Honorable Mention: Inteccon, Inc.

Inteccon, Inc. goes above and beyond to provide excellent customer service by holding customer support seminars, training, and general customer visits. They protect the vulnerable by partnering with government agencies to ensure the safe working conditions.

BGI Environmental Instruments

Winner: Inteccon, Inc.

Inteccon, Inc. thrives in protecting the vulnerable through collaborating with governments and specialists throughout Latin America to install superior ambient air monitoring systems. They are a valuable partner to Mesa as they help their customers measure critical parameters to keep everyone safe from air pollution risks.

Honorable Mention: Pacwill Environmental

Pacwill Environmental has been protecting the vulnerable for over twenty years by providing quality air and process gas measurement equipment. Even though they are a small team, they continue to give back to their customers in big ways through quality service and support.

Biological Indicators 

Winner: AR BROWN

AR BROWN is our hardworking and determined team from Japan who has ample knowledge of Mesa’s Biological Indicators (BI). They are passionate about bringing high quality products that help ensure sterility within the life sciences community – bringing an end to healthcare-associated infections (HAIs) and protecting the vulnerable. 

Honorable Mention: ST Pack

ST Pack is our highly motivated Biological Indicator (BI) partner in Argentina. They are dedicated to learning all they can about BI product lines, which will better help customers achieve sterilization assurance. ST Pack knows that BI products are an essential part of protecting the vulnerable from deadly contamination in hospitals.

With help from our valued channel partners, Mesa ensures the results we deliver to customers are greater than the products we make. Thank you to all our channel partners for dedicating your time and helping us protect the vulnerable. To learn more, visit mesalabs.com/aboutus.

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.

Unit Dose Packaging For Diagnostic Products

Improving safety standards and efficiency is an ongoing goal shared by medical staff, especially in hospitals. Unit dose packaging was developed as a solution to help improve safety concerns for both hospital staff and patients. The unit dose packaging definition is “a dose of medicine prepared in an individual packet for convenience, safety, and monitoring.”

Over time, innovative pharmaceutical packaging companies improved on the original concepts found in unit dose packaging. Here at LF of America, for example, we produce eco-friendly unit dose containers for liquids. Our unit dose containers come in interconnected strips of five separate ampoules and can even be produced with re-closable seal options for multi-use applications.

Continuous development of pharmaceutical packaging options like unit dose packaging is an important part of improving the medical and related industries. In addition, the benefits of unit dose packaging extend beyond improving safety, which you can read more about below. To learn more about our unit dose packaging options, please contact LF of America for further assistance.

Benefits of Unit Dose Packaging

Going back to the definition of unit dose packaging, single dose containers must meet the criteria of improving convenience, safety, and monitoring. First, single dose packaging eliminates the need for measuring out dose after dose while reducing inaccurate dosing concerns. Because they are also individually barcoded, the administration of single dose containers can be easily monitored by staff members.

Another advantage to single dose containers is directed at patients. When used in hospital settings, patients can pay for only the doses they use instead of having to purchase full bottles. The containers themselves are also more hygienic than traditional containers and are easy to bring anywhere the patient might need to take them.

The primary reasons to consider unit dose packaging are:

  • Improving safety for staff and patients
  • Eliminating inaccurate dosing concerns
  • Having electronic documentation for easy monitoring
  • Easy to find potentially damaged containers
  • Reducing unnecessary costs to patients

Please watch the video below if you’d like to learn more about the unit dose packaging we have available at LF of America.

Automatic Product Detection Torque Testing Head

While automated torque testers eliminate the ergonomic concerns of manual torque testing, they often require a trained mechanic to adjust the hardware and software configuration when changing over from one product to another. To overcome the complexity of the setup, Mesa Labs is now offering magnetically coded locator bases.

Features:

  • Environmentally friendly 3D precision printed acrylic locator bases
  • Highly resistant to corrosion and typical cleaning materials (IP, H2O2, Spor-Klenz), ideal for pharmaceutical cleanroom areas, beverage and chemical production facilities
  • Eliminates the need for mechanical and software setup adjustments
  • Custom engineered for each unique product for horizontal (centering) and height positioning
  • Unique, 5 position magnetic coding allows the automatic identification of up to 32 products
  • Available as an option for ST-S3 and ST-120s torque testers
  • Compatible with tubes, vials, and most pharmaceutical bottles*

*Sample bottles/caps are required for compatibility testing

For more information on the current Torque Testing Solutions we provide give us a call at 800-829-5741

PREFILLED SYRINGES INTEGRITY TESTER

The PK-SY is Bonfiglioli Engineering ONLINE PREFILLED SYRINGES CONTAINER CLOSURE INTEGRITY TESTER.

The Leak Testing Machine is used for in-line Non-Destructive Container Closure Integrity Testing. It performs the Leak Testing process in continuous operation by means of Testing Chambers under Vacuum which are installed on to a rotating Central Carousel. Following Leak Testing process, the Containers are automatically unloaded from Testing Area and they are managed according to the result. Whether the result is Conforming or Non Conforming, the HMI clearly displays the status. The Measurement System provides both a “gross” and a “fine” leak test detection range.

KEY BENEFITS

  • High speed leak testing
  • Non Destructive
  • Rapid and accurate analysis
  • 100% control and not statistical
  • Homogeneous leak detection
  • Easy validation and leakage certification
  • Automatic cleaning pocket to avoid false rejects
  • No alteration of product’s properties
  • Easy access and cleaning
  • Low energy consumption
  • Displaying recording and printing of the tests results
  • Software based on SCADA platform
  • Can be configured to comply with CFR21 part II norms

Interested in more quality control solutions, contact our project engineers at 800-829-5741.

Ampule Filling and Sealing Machines

Cozzoli’s stainless steel FPS Series is ideal for filling and sealing ampules with speeds from 15-120 ampules per minute and a fill accuracy of +/- .5%. The FPS is designed with a sealed top cover plate to ensure the internal drive mechanism remains free of extraneous matter.

The FPS series is a compact ampule filling and sealing monoblock machine; featuring an unscrambler, flushing and filling stations and is known for it’s simplicity, operational reliability and minimal maintenance factors.

Utilizing Cozzoli’s exclusively patented sliding tube valve, the FPS uses stainless steel syringes and positive head pressure to fill product with outer diameter dimensions up to 1” (25.4mm) at full speed. Ampules from 25.4mm to 28.6mm can be handled by alternate indexing.

Fill volume can be changed by a simple adjustment of a calibrated sector arm. Volumetric accuracy of fill is +/- 0.5%. Bottom-up filling is provided through the provision of two cams to lower and raise on a 2” or 5” stroke. Other cams are available for any special bottom up filling requirements.

Since the blending of proper amounts of oxygen and gas is important for effective sealing of the ampule, this machine can be optionally equipped with a dual flow meter assembly that will visually indicate the oxygen and gas flow separately.

Contact our office to learn more about our Ampule filling solutions and to discuss current pricings.

Unit Dose Packaging by LF of America

Improving safety standards and efficiency is an ongoing goal shared by medical staff, especially in hospitals. Unit dose packaging was developed as a solution to help improve safety concerns for both hospital staff and patients. The unit dose packaging definition is “a dose of medicine prepared in an individual packet for convenience, safety, and monitoring.”

Over time, innovative pharmaceutical packaging companies improved on the original concepts found in unit dose packaging. Here at LF of America, for example, we produce eco-friendly unit dose containers for liquids. Our unit dose containers come in interconnected strips of five separate ampoules and can even be produced with reclosable seal options for multi-use applications.

Continuous development of pharmaceutical packaging options like unit dose packaging is an important part of improving the medical and related industries. In addition, the benefits of unit dose packaging extend beyond improving safety, which you can read more about below. To learn more about our unit dose packaging options, please contact us at 800-829-5741 for further assistance.

Benefits of Unit Dose Packaging

Going back to the definition of unit dose packaging, single dose containers must meet the criteria of improving convenience, safety, and monitoring. First, single dose packaging eliminates the need for measuring out dose after dose while reducing inaccurate dosing concerns. Because they are also individually barcoded, the administration of single dose containers can be easily monitored by staff members.

Another advantage to single dose containers is directed at patients. When used in hospital settings, patients can pay for only the doses they use instead of having to purchase full bottles. The containers themselves are also more hygienic than traditional containers and are easy to bring anywhere the patient might need to take them.

The primary reasons to consider unit dose packaging are:

  • Improving safety for staff and patients
  • Eliminating inaccurate dosing concerns
  • Having electronic documentation for easy monitoring
  • Easy to find potentially damaged containers
  • Reducing unnecessary costs to patients

Please watch the video below if you’d like to learn more about the unit dose packaging we have available at LF of America.

Expert Environmental Solutions by Bahnson

Bahnson Environmental Specialties designs and fabricates a diverse product line of controlled environment chambers that create a precise environment for clients’ research, development and manufacturing processes. 

Various standard and custom sizes serve as Walk-In Cold Rooms and Walk-In Freezers including Walk-In Ultra Low Freezers and Vaccine Storage Chambers.

Walk-In Environmental Rooms include Walk-In Temperature and Humidity Chambers, Walk-In Warm Rooms, Walk-In Incubators, ICH Stability Rooms and Shelf Life Study Chambers.

HEPA Filtered Clean Cold Rooms, HEPA Filtered Clean Warm Rooms, Growth Chambers, Shelf Lighted Rooms, Dry Rooms and Low Humidity Dry Rooms are included in our Walk-In Environmental Chamber Series. Custom Walk-In Environmental Room applications include Test chambers, Cascade Low Temperature Freezers for critical long term storage and archival storage rooms and vaults.

Next, Bahnson provides full mechanical services, including hygienic piping, process piping, HVAC and plumbing for Life Sciences operations throughout the United States. In the mid 1990s Bahnson developed and implemented its quality assurance program to support the company’s fabrication and field construction activities for the installation of piping systems within the guidelines of Good Manufacturing Practices (GMP). The Standard Operating Procedures (SOPs) evolving from this effort have enabled Bahnson to execute projects effectively and consistently producing high quality levels in a wide range of installations over the past several years.

Today, Bahnson continues to pursue contracts with complex mechanical systems including sophisticated process and high purity piping systems requiring the highest levels of quality assurance, project management, safety awareness, and financial capability.

BES offers a complete package of services for our chambers as well as other chamber manufacturers and laboratory equipment.

Located throughout the country, our service technicians have the training and expertise required to ensure that your equipment is always performing at its best.

We understand the criticality of your equipment and have a 24 hour Emergency Service Hotline.

Bahnson Environmental Services include:

  • Pre-Sales Support
  • Architectural Design
  • Mechanical Design
  • Electrical/Controls Design
  • Project Management
  • Field Installation
  • Validation & Qualification
  • Preventive Maintenance & Calibration
  • Emergency Service & Repair
  • Technical Support
  • Parts Distribution

To learn more about or service capabilities, please contact us at  800-829-5741

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