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

Cozzoli Introduces Lower Parts Pricing

With the on-going trade tensions, we know that many of our customers have taken on the burden of dealing with tariffs which have increased their cost of doing business.

Cozzoli are committed to help remove some of that burden, so today we are announcing that we have dropped prices on most of our parts.

By becoming more lean in our manufacturing processes, we are now able to produce parts at a lower cost. To best take advantage of these lower costs, we want to pass along the savings to our customers.

Call us today, and request an updated quote on the interchangeable parts and tooling we are currently offering for all Cozzoli products.

Call our office 800 829 5741 and we’ll glad to be of assistance.

Revamp your old Quality Control equipment

Your old machinery can be upgraded with the latest generation technology to increase machine life and achieve higher performance in terms of productivity, include remote access & increase autonomy of maintenance; all of this with no downtime?  

Bonfiglioli Engineering, the worldwide leader in quality control solutions, continuously supports its clients to update their equipment with the most advanced solutions available in the field: UPGRADE III.

UPGRADE III is the substitution of all obsolete or phased out parts of the machine, for both hardware & software, with new latest generation material that is readily available in the market, including microprocessor, PLC, UPGRADE III Invertor and electrical board.

UPGRADE III offers many new features designed to improve functionality, accessibility, and reporting. Here are the reasons why you should upgrade your machinery: 

LONGER MACHINE LIFE 

REDUCED COSTS 

NO DOWNTIME 

AUTONOMY IN MAINTENANCE 

REMOTE ACCESS 

INDUSTRY 4.0 SYSTEM COMPLIANCY 

Customized maintenance contracts complete with worldwide dedicated technical services are also available to meet the specific customer’s requirements.  

Discover the solution most suitable for you! 

Contact us to receive your personal quotation:

Call 800-829-5741

Or email our product specialists

LF of America – Packaging Machine Manufacturers

Depending on your product or the size of your operation, incorporating automatic packaging machines in-house can present numerous benefits. Packaging machine manufacturers provide this such opportunity to business owners looking to take full control of their production.

There are, however, a number of packaging machine manufacturers that produce and supply packaging equipment intended for a diverse variety of industries. In order to get the most from your investment, it’s best to learn some information about what sets different packaging machines apart.

Packaging Machine Types

Packaging machine types vary depending on the type of materials you are handling. You will need to find packaging machine manufacturers that offer the type of equipment capable of managing your product consistency (liquids, solids, gels, powders, etc.) as well as the containers themselves.

The different types of packaging equipment options also include sub-categories, such as bottle equipment, automatic capping machines, and labeling machines. In addition, there are packaging machines for plastic containers, pharmaceutical packaging machinery, blister packaging, unit dose packaging, and many other options.

Automatic Packaging Machines For Liquids

LF of America specializes in providing innovative contract packaging solutions for a growing variety of different purposes. We are proud to be leaders among packaging machine manufacturers in the USA.

Our available packaging machine units are capable of everything from small to medium batches to full-size production. They offer companies with items such as cosmetics, OTC pharmaceuticals, diagnostic products, CBD oils, or even veterinary and animal care medications the opportunity to gain full independence over their production.

Shown below, our Pentafill A25 fills up to 25 vials per minute for containers ranging in size from 0.33 – 1 ml. For packaging plastic containers ranging in size from 2 – 10 ml, it is capable of filling as many as 23 vials per minute.

Our Bellow Bottle Machine units are automatic capping and filling machines also capable of various production levels. They are designed to handle filling liquids, gels, creams, serums, and powder. Altogether, these units can cap and fill up to 25 containers per minute. Learn more about the Bellow Bottle Machine in the video posted below.

Many savvy business owners and production managers are beginning to understand the overall value of investing in their own packing equipment. Packaging machine manufacturers like ourselves make that possibility a reality.

If you would like to know more about any of our units or are interested in learning the cost of purchasing your own packaging machine, contact us today 800-829-5741.

The most versatile testing solution available

The SAIL is Bonfiglioli’s new automated inspection laboratory for different container types, sizes, and content bringing together CCIT, AVI and HGA technologies is an all-in-one machine that is suitable for in-process control, clinical trials, and laboratory use.

HIGHLIGHTS

 SAIL modular structure provides adequate flexibility upon all 3 of testing technologies:

– AVI (Automatic Visual Inspection)/ SAVI a collection of images is acquired using high resolution matrix cameras under designed illumination conditions.

– CCIT (Container Closure Integrity Testing) non-destructive integrity testing in packages by Vacuum Decay Method.

– HGA (Headspace Gas Analysis) inspection process is based on the Tunable Diode Laser Absorption Spectroscopy (TDLAS) method which accurately quantifies gaseous concentration levels.

• All in one Industry 4.0 based
   laboratory
• Ergonomic workstation
• Scientific and objective inspection
• 100% traceability
• Time & cost saving

SAIL modular structure provides adequate flexibility for all 3 testing technologies:

– AVI (Automatic Visual Inspection) /SAVI

– CCIT (Container Closure Integrity Testing)

– HGA (Headspace Gas Analysis)

The testing methods conform to current pharmaceutical regulations, such as FDA 21 CFR Part 11 and EU Annex 11USP General Chapter <790>ASTM F2338-09USP General Chapter <1207>EU Annex 15 and GMP requirements.

Contact our offices today to learn more about the SAIL.

CLEANING GUIDELINES VALVE ASSEMBLES AND SYRINGES

Regularly scheduled preventive maintenance minimizes downtime and assures trouble-free operation!M

Cozzoli’s exclusive sliding valve assemblies and precision honed syringes are mated for life and operate as matched sets on liquid fillers.

Each set is engraved with matching serial numbers that correspond accordingly. It’s important never to mix up or interchange designated serial numbers with other valves and syringes, as damage and poor operational permanence will result.

DISASSEMBLE AND ASSEMBLE

When disassembling, always withdraw the piston in a straight, horizontal line in reference to the valve or the syringe body.

Reverse this procedure to assemble.

Never use force, as it will cause the components to jam.

BEFORE USING

Before the initial use of valve assemblies and syringes, clean and rinse with a solution of soap and water, then flush thoroughly with clean water.

Place them on a lint-free cloth or paper.

Do not allow components to come in contact with contaminants or other metal parts after cleaning.

AFTER USING

Product should not be allowed to dry in the valves and syringes since it could cause them to score or seize.

Always disassemble them and clean properly with an appropriate solution that will remove product.

A bristle brush with a plastic center may be used. Blow dry components thoroughly to ensure that they are free of foreign particles and watermarks. When autoclaving, be sure that the piston is removed from the valve or syringe body.

WHILE IN OPERATION

Valves and syringes should never run dry while in operation. Either product or water must be present.

HANDLE WITH CARE

Proper valve and syringe handling is essential. Dropping, hammering on or restraining them in a vise may damage and render them inoperable.

PRIOR TO INSTALLATION

Check action of valve and piston within syringe cylinder to ensure smooth performance prior to installing on filler.

STORAGE

Between uses, valves and syringes to be stored wrapped in a lint-free cloth or paper.

This is necessary to avoid contamination and contact with other metal components.

Contact our offices to learn more about Cozzoli Machine Company and their comprehensive product line.

Contract Filling Services For Liquids

Reliability is a necessary trait in the packaging industry. If you aren’t able to depend on the contract filling services you require for distribution, it’s your own business’ reputation that hurts.

Without proper handling, your product could become less effective or end up becoming tainted. Contract filling companies need to have access to the right resources and carefully developed plans to ensure product safety.

This is as true for health and beauty products or cosmetics, for pharmaceuticals and diagnostic products. Simply put, you need a packaging company you can trust to handle your products safely from end to end. We are that solution.

Your Source For Reliable Contract Filling Services

LF of America is the leading provider of contract filling services and liquid packaging solutions in the US. Our team of technicians believes that each time a client entrusts us with handling their products, we become an extension of their business.

For this reason, we put a strong emphasis on safety and compliance during the filling process. It’s important to us that each and every one of our clients knows they can rely on our contract filling service to be done safely and on schedule.

In order to accomplish this, our contract filling services are handled in our state of the art facility within contained settings. We have access to some of the most advanced automatic filling and sealing machines available, which are equally capable of handling small batch orders all the way up to full-scale production sizes.

The filling and sealing machines are stationed inside our ISO-8 cleanroom. The ISO-8 cleanroom is immaculately maintained in order to remain in total compliance with Cosmetic GMP regulations, an extension of the Quality System Requirements for medical devices.

Our contract filling services regularly handle each of the following:

  • Liquid Cosmetics (Most viscosities, including creams, gels, powders)
  • Gel & Liquid Diagnostic Products
  • OTC Pharmaceuticals
  • CBD Oils
  • Veterinary & Animal Care Products

For packaging options, our contract filling services can be performed using your own existing containers or you can choose from our diverse variety of packaging types. Our collection of innovative packaging options include unit-dose packaging, Bellow Bottles, wand tubes, enema containers, bottles with droppers, dual chamber bottles, and more.

All of the different types of options available through our packaging manufacturing department are suitable for many different applications. Please fill out an inquiry form to request our help with developing a unique packaging solution that is ideal for your intended purposes.

If you would like to receive a free estimate regarding the cost of our contract filling services, call our office at 800-829-5741.

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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