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

Fedegari Eco Steam Washers

FSW Eco-Steam Washer is the latest industrial innovation of Fedegari Group addressing pharma, food and cosmetic industries. FSW Eco-Steam Washer innovates the concept of GMP washing thanks to the use of steam in the washing cycle. Fedegari has decades of experience in steam technology. Due to this fact, FSW Eco-Steam Washer has been designed in an original way, if compared to traditional industrial washing machines.

Steam works as cleaning agent and water heating. The direct injection of steam into the washer chamber avoids the need for additional heating elements and results in a cleaner in-chamber environment. In case of need, FSW Eco-Steam Washer can be equipped with a steam generator.

Due to its emollient effect on greasy and sticky dirt, the steam reduces the use of detergents and improves chamber and load sanification. During the washing cycle, the injection of clean compressed air filtered by the Pall vent filter (0.22 µm) increases the mechanical action of washing/rinsing through the chamber.

Final drying is performed with hot air filtered by Hepa filter H14 injected in chamber, in order to assure the total drying of the machine and of the load.

DESIGN AND TECHNICAL FEAUTURES

  • Chamber and hydraulic components made of AISI 316L stainless steel with sanitary finishing
  • The door (hinged or sliding) is made of glass with the perimeter reinforcement made of AISI316L stainless steel
  • Fully modular and customizable internal trolley: it can be designed according to the customer’s load
  • Internal trolleys are designed to avoid any water stagnation thanks to dedicated draining points
  • Thema4 process controller ensures a total control on washing performance, therefore a robust reliability during inspection and validation activities
  • In case of emergency, alarms are audible and visible: an internal LED lamp is operative during the whole cycle and its alarms operates through LED color change.

KEY BENEFITS

  • The power of steam: emollient effect and sanification agent
  • Eco-solution: less detergents, less energy and water consumption
  • High customization of washing process
  • Custom-made internal trolleys
  • Process monitoring system

To learn more about the Fedegari FSW Steam Washer and its capabilities get in touch with our head office and speak with our project engineers 800-829-5741.

Why to Invest in a Liquid Filling Machine

Many times companies depend on contract filling services to fulfill their packaging needs. Contract packaging and filling companies like ourselves give clients the opportunity to have all of their requirements completed under one roof. However, over time, production needs can change, motivating businesses to look at investing in their own filling equipment.  Owning an in-house liquid filling machine comes with various advantages, making it a prudent financial investment.

For this reason, LF of America offers companies the option to invest in their very own automatic liquid filling machine for plastic containers. Learn more about our line of filling machinery below or contact us to receive further details. If you’re still not prepared to invest in your own in-house filling machine, consider LF of America your perfect turnkey partner for all packaging and filling needs.

How Our Liquid Filling Machine Works

Safe packaging is a necessity for all companies within the pharmaceutical, health and beauty cosmetics, veterinary medicine, and diagnostic industries. Product safety is of paramount importance and requires logistical planning throughout every phase of the production process, including filling and sealing.

Our available contract filling equipment for sale exceeds all the safety standards while delivering truly reliable results. The Pentafill Machines utilize blow, fill, and seal technology in combination with injection molding. The advantages of using blow, fill, and seal with injection molding are increasing safety throughout the process.

Rather than risk contact between product and heat by combining the blow and fill process, a potential danger which could damage the product, our liquid filling machine fills the containers first. Next, the containers are moved along for a separate heat blow process, ensuring no contact to the product. Then, the heat seal #1 and #2 take place. Finally, cold crimping completes the filling before unloading the containers to pick up.

To learn more about our liquid filling machinery, contact our corporate HQ via 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.

FEDEGARI PRESENTS ADVANCED PHARMA TECHNOLOGIES

Fedegari Group demonstrated a working, prototypical pharma sterilization production line at Interphex, Booth 3461 at the Javits Center in New York, USA.

Jeffrey Siterlet, Managing Director of Fedegari Technologies announced that the company will exhibit its state-of-the-art sterilization, washing and decontamination technology at the upcoming Interphex show, booth 3461.  The highlight of the display will be Fedegari’s innovative multi-process system, simulating an operational pharma production process.  It will demonstrate the integration of a number of processes, including sterilization, washing, chemical bio-decontamination, robotic handling and others, in order to speed production, reduce footprint while eliminating contamination risk.

Operation of the system is coordinated utilizing the one of the fastest and most flexible process controllers in the industry, the Thema4, also designed and produced by Fedegari Group, a global leader and pioneer in sterilization, washing, and bio-decontamination technology for over 65 years. Because Fedegari’s controller technology is proprietary and is based in VxWorks, it is also 100% immune to hacking and tampering.

Said Siterlet, “The more manual steps that are in the pharma manufacturing line, the greater the risk of contamination.  The Fedegari system reflects a visionary approach to streamlining new technologies, like robotics and IoT, into the process. Our system eliminates all disconnection by completely enclosing the process and centralizing the control to provide efficiency, safety and compliance without equal.”

To enable bio/pharma customers and prospects to more easily visualize their individual processes, issues and needs, Fedegari Group recently opened its Tech Center in suburban Philadelphia. The Tech Center is designed to be an industry resource, equipped with various process components and simulators for hands-on testing and training, replicating the same activities pharma industries utilize at their own bio/pharma manufacturing plants.

Interested in getting more information about Fedegari products? Get in touch with our pharma tech project specialists at 800-829-5741.

Cozzoli CR Series liquid filling for pharmaceuticals

Cozzoli’s Model CR200/400 provides continuous-motion filling and stoppering of liquid pharmaceuticals. Offering production speeds up to 200 and 400 containers per minute respectively, this machine performs with outstanding volumetric accuracies of +\-0.5% of fill volume, or better, with either full or partial insertion of stoppers.

FEATURES

Production and cost saving features include compact size, machine taking up less than 46 sq. ft. of floor space, quick and easy changeover, and a vibratory bowl handling stopper sizes of 13 to 20mm or 20 to 28mm. When used with laminar flow, the CR400’s open flow-through design of the central star-wheel significantly lowers particle counts to well under GMP standards for use in Class 100 cleanrooms. This microprocessor controlled machine features a stainless steel exterior with all liquid contact parts fabricated of 316 stainless steel and medical grade silicone to accommodate sterile requirements. It also provides missing container, make-up and back-up detection systems.

OPERATING PRINCIPLE

Containers enter the machine via the infeed conveyor, where they are transported single file into a Delrin timing screw where they are precisely spaced into star wheel pockets. Containers are then transferred into a larger main starwheel where the filling operation occurs. After filling, containers travel to the exit starwheel for stopper positioning and insertion. The continuous motion handling of the containers reduces machine wear, and provides for gentle handling of the containers.

STANDARD FEATURES

Syringe Assemblies Nozzle Assemblies Tygon Tubing 1 Set of Vial Change Parts Vibratory Bowl Stopper Feed Assembly Stopper Delivery Assembly Valve Assemblies Down Vial Eliminator Upstream Make Up Sensor System Downstream Back Up Sensor System Electronic Digital Rate Indicator (LED) 9′ Center to Center Conveyor Assembly 303/304 Stainless Steel Exterior Construction Microprocessor Control DC Machine Drive NEMA 4, 220V, 60Hz, 1 Ph Electrical Full Color Operator Panel Password Protected Operating Parameters

OPTIONAL FEATURES

  • Lexan Enclosure
  • Additional Change Parts
  • Additional Nozzle Sizes
  • Ethernet PLC Upgrade

Contact the Life Scientific, Inc. Project specialists for further information regarding the latest updates and quotes of the liquid filling solutions for pharmaceuticals

Introduction to Single Dose Packaging

The introduction of single dose packaging has become a breakthrough across a diverse variety of applications and industries. Single dose packaging, also known as unit dose packaging, has given hospitals, pharmaceutical companies, and patients more control over their medication while simultaneously reducing waste. It’s also become a popular commodity used by cosmetic manufacturers due to its small, easy to carry unit size.

So what makes unit dose packaging such an innovative development in the packing field? What benefits does single dose packaging provide companies and how is it best utilized? The purpose of this article is to answer these questions thoroughly while covering the many advantages incorporating unit dose packaging in various applications. Keep reading to learn why a unit dose delivery system might be perfect for your product.

Advantages of Single Dose Packaging

As implied by its name, a single dose package safely holds a single premeasured unit of a particular medicine or substance. Having a dose already measured out eliminates the possibility of human error while adding convenience for the user during application. Moreover, its materials are made of eco-friendly bioplasticfrom 100% renewable sources, reducing our dependence on diminishing resources and lessening waste.

The advantages of single dose packaging in clinical and hospital settings are as follows:

  • Improved application accuracy for patients and personnel
  • Reduction in waste and unnecessary bottles and containers
  • Barcodes that identify each individual dose
  • Easily identifying tampered or broken packages
  • Patient is only responsible for exact doses delivered
  • Simple electronic documentation capabilities

There is an obvious advantage for people to have their medication already measured out prior to administration. There are, however, also other advantageous benefits that have since become widely utilized by other forward-thinking businesses in a wide range of other industries. Because of its diverse functionality, unit dose packaging is also now commonly found utilized in cosmetics, OTC products, veterinary and animal care, and even diagnostics.

More Single Dose Packaging Applications:

In cosmetics, health and beauty products are often handed out as samples for consumers to try. Utilizing the convenient size and protection of unit dose packaging, handing out lotion, gel, perfume, or other samples in an easy-to-carry, premeasured package has never been more effective. Similarly, diagnostic test kits in single dose containers eliminate potential human error while increasing the convenience for personnel.

As more businesses discuss the benefits of incorporating innovative packaging into their brand, surely even more uses will continue to develop. One such recent market that has grown to embrace its advantages is packaging for CBD products. If you, too, believe unit dose packaging might be right for your product or application, contact us today. We’ll gladly assist you and tell you how to receive some free samples filled with your product. Call 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.

Plastic Vials For Injectables

The use of glass ampoules has been the most common standard for containing sensitive pharmaceuticals and biotech products since its inception over a century ago. However, with the proliferation of more innovative packaging solutions, many pharmaceutical manufacturers are adopting plastic vials for injectables due to the reduction in drawbacks attributed to packaging products in glass containers.

LF of America is an innovative packaging company intent on delivering new solutions that meet the challenges faced throughout the pharmaceutical industry. We’re proud to announce our latest solution for reducing the contaminant concerns and fragile qualities of glass containers, challenges pharmaceutical manufacturers and industry workers encounter regularly. Our new plastic vials with luer lock fittings for injectables are a safe and practical alternative to glass ampoules and prefilled syringe storage.

Benefits Of Plastic Vials For Injectables

Vials storing injectables are required to meet strict regulatory standards for product safety assurances. Although glass ampoules have excellent barrier properties, chemical resistance, and remain generally compliant, the increasing demand for lightweight and durable pharmaceutical packaging options continues. The fragility of glass, along with drug and container interaction concerns, has led to a growing interest in plastic vials designed to efficiently fill, ship, store, and administer injectables safely.

What our new plastic vials provide manufacturers and industry professionals is the ability to achieve all of these goals without the dangers associated with glass storage. From production to administration, every step of the process can be assisted by the dependability of this innovative packaging option. Designed with a luer lock fitting, the empty syringe screws directly into the luer on the vial for safe liquid transfer. Once the content exchange is completed, the vial can be disposed of while the syringe is prepared for administration via a needle or directly.

The benefits of adopting our new plastic vials for injectables include:

  • Eliminating glass breakage during filling, shipping, storage, and administration
  • Less risk of drug/ container interaction
  • Lightweight, break-resistant materials
  • Greater design flexibility
  • Less space needed for product storage than prefilled syringes

The plastic vials for injectables are designed as unit-dose packaging systems in 5-vial strips. Currently available in 10 mL and 20 mL capacity, each plastic vial can also be designed to hold the precise measurement for the appropriate single dose amount in any container size required.

Filling Plastic Vials For Injectables

LF of America is proud to be a turnkey contract packaging and filling company. We provide contract filling services using state-of-the-art machines equipped with fill and seal and injection molding technology. Each fill is performed inside a completely sterile ISO-5 environment for quality and safety assurance. In addition, our filling machines are available to buy directly for manufacturers and companies looking to incorporate their own in-house packaging solution.

To discuss our contract packaging and filling services or for other questions regarding our new plastic vials for injectables,  please call our offices and connect to our project specialists 800-829-5741

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