NEED OF A VACUUM CONVEYOR?

You have a great product with a marvelous container that will win your customer over because of its shape but…your regular conveyor is no more the best solution to handle this new container since its shape makes it quite difficult to be handled this way…

Here is a good solution that is ideal for conveying containers that otherwise would be unstable. VACUUM TECH is the vacuum conveyor created by Vetromeccanica that won’t disappoint you in handling this tough call.

The only requirement a container must have in order to be conveyed by VACUUM TECH is that the base of the bottle must have an adequate shape in order to be aspired and so making vacuum among the bottle base and the chain.

Contact us for more information: 800-829-5741

The Improvements in Ophthalmic Packaging

There are a number of ophthalmic diseases and eye irritations that require eye care medication to treat properly. Fortunately, the vast majority of ophthalmic medication is derived from a fairly simple solution. However, many ophthalmic packaging options have limitations and can even require irritating additives to be used in the formula.

In order to resolve the limitations of traditional ophthalmic packaging, many pharmaceutical companies are looking to contract packaging and filling experts for help. One of the more recent innovative advancements in eye drop packaging is through unit-dose packaging. Incorporating single use packaging for eye dropsprovides a number of useful advantages for the companies and users alike.

The following article will highlight the different ways that unit dose packaging can improve the storage and use of ophthalmic medication. If you’re interested in discussing eye medication packaging options with the premier contract packaging and filling company, contact LF of America for assistance.

The typical eye medication packaging is comprised of a bottle, dispensing tip, and tamper-resistant features. Standard bottles with droppers have been widely used for decades thanks to their affordability and durability. Although these standard eye medication containers are useful, they still have a few significant disadvantages.

Traditionally, liquid ophthalmic drug products come in multi-dose containers that are designed to protect the quality of the product, aid in dosing, minimize contamination concerns, and maintain overall sterility. The majority of ophthalmic products in multi-dose containers are intended to be used within a month after opening.

The primary concerns with traditional eye medication packaging are associated with dosing and storage. First, it can be difficult for users to apply a precise dose of the medication equally in both eyes. Second, because of the chemical interactions between the solution and the materials used in the container, preservatives are added that produce a burning sensation once the product is used.

In order to combat these disadvantages, LF of America has designed a more innovative ophthalmic packaging option that overcomes these problems. Using patented multi-layer technology and a 100% preservative-free formula, our unit dose packaging for eye drops makes administration easier and more comfortable. In addition, the single dose container permits users to easily administer the same precise dose in both eyes.

The benefits of our unit dose ophthalmic packaging over traditional eye drop containers include:

  • 100% Preservative Free Formula (no burning sensation caused by irritating additives)
  • Equal API Delivery in Each Eye
  • Two Piece Unit-Dose Vial with Clean Orifice for Calibrated Drops
  • More Comfortable Administration (no plastic flashes on opening)
  • Injection Molding Technology (increased safety and flexibility)

To learn more about our innovative eye medication packaging options, please contact our representatives.

PHARMA TECHNOLOGY FOR LABORATORY SOLUTIONS

More than 60 years manufacturing components, systems and sub-systems in-house for the most demanding users. An in-depth knowledge hard to beat. Fedegari laboratory range offers to customers all the innovation already tested in the pharma industry. The same components, the same process controller, customized to meet specific laboratory needs.

Today, Fedegari is the only manufacturer of lab equipment that is developing its machines by adopting sophisticated solutions already field-tested on the pharmaceutical market by the most demanding users.

Thema4LabTHE PHARMA PROCESS CONTROLLER CUSTOMIZED FOR LAB APPLICATIONS

Engineered and pre-validated by Fedegari according to GAMP 5, Thema4Lab process controller is a revolutionary solution: a completely customized system for laboratory needs that benefits from the pharmaceutical expertise of the industrial Thema4 process controller. This innovative system guarantee a reliable and cost-effective process development and is already available on FOB5 steam sterilizers and FGW glassware washers.

FGW LAB WASHER – FEDEGARI EXPANDS ITS RANGE OF LABORATORY SOLUTIONS 

Fedegari’s latest innovation for laboratory market is a glassware washer that capitalizes the experience acquired with the FOWS-series of washers in the pharmaceutical market. The new FGW lab washer, in fact, uses a steam generator to improve washing performances reducing operating costs. This true eco-friendly solution minimizes the use of detergents as well as water consumption. Not only, the pre-validated Thema4Lab process controller uses a conductivity meter to terminate the process as soon as the desired set point is reached thus further reducing water and other utilities consumption.

The piping, as for any other equipment manufactured by Fedegari, has a rigorous sanitary finishing. The machine is then loaded with a modular, customizable rack that can be easily adapted to all load configurations. As for all Fedegari lab equipment, the FGW complies with cGLP standards. FGW external trolleys are interchangeable with FOB5 steam sterilizers and components are standardized for both machines representing a cost-effective solution for high performance laboratories.

Contact our corporate offices at 800-829-5741 for further information.

Single Use Pharmaceutical Packaging For Eye Drops

Many forward-thinking companies are always looking for ways to improve their products. Finding practical improvements that benefit consumers in any area of operations has the potential to give pharmaceutical companies an edge over their competitors. One area that many companies are now embracing involve using single use pharmaceutical packaging.

This growing trend for incorporating single use pharmaceutical packaging is being especially embraced by manufacturers of ophthalmic medication like eye drops. There are many useful benefits for using unit dose containers for eye drops instead of the traditional standard dropper bottle.

The following article will highlight the advantages of single use pharmaceutical packaging for ophthalmic medication. It will also provide some information on the innovative pharmaceutical packaging and filling options we have available at LF of America. If you’d like to learn more about our unit dose packaging options or wish to discuss incorporating any of our contract packaging and filling services into your operation, please contact us for more assistance.

Advantages of Single Use Packaging For Eye Drops

Standard eye dropper bottles for ophthalmic medication has been the most common packaging option for countless years. This is predominantly because eye dropper bottles were easy to produce, fill, package, and distribute. However, there are a few common limitations that inspired companies to come up with modern solutions.

Some of these limitations are proper dosing in each eye and shelf-life concerns, which contributes to adding preservatives that create a burning sensation. Fortunately, unit dose packaging for eye drops successfully overcomes these challenges. LF of America is proud to be at the forefront of this development and has patented a specific multi-layer packaging for eye drops.

The benefits of our unit dose packaging for ophthalmic medication include:

  • Preservative Free Formula (No Burning Sensation)
  • Equal Delivery of API (Active Pharmaceutical Ingredient) in Both Eyes
  • Two Piece Unit-Dose Vial with Clean Orifice for Calibrated Drops
  • No Plastic Flashes on Opening to Improve User Experience
  • Injection Molding Technology for Flexibility & Product Safety

Contact our sales representatives via 800-829-5741 to request a free packaging samples for your product.

FLOW CONTROL solutions by Vetromeccanica

Vetromeccanica designs and manufactures systems for the production flow control.  Our dividers and mergers allow to efficiently and safety move the products from one line to 2 or more lines and vice versa.

VETROMECCANICA’S DIVIDERS AND MERGERS BENEFITS

–   SPECIFIC MODELS TO MATCH SPECIFIC NEEDS  
We design and produce different types of dividers and mergers cause each type matches very specific needs. Moreover, we can customize them, if it is necessary because of particular technical line requirements.

–   MAXIMUM FLEXIBILITY IN HANDLING ANY KIND OF CONTAINER SHAPE  
Vetromeccanica offers conveying solutions that can easily adapt to every container type.

–   STURDINESS AND ALMOST NO MAINTENANCE NEEDS  
We produce our TableTech starting from plates of AISI304 certified stainless-steel.  
Our conveying solutions are design to guarantee high performances, a long-life service and to simplify and minimize as much as possible the maintenance operations

  –  CONTROL PANEL AND TOUCH SCREEN

Contact LSI now and schedule a meeting with the conveyance solution experts from Vetro. We expect to hear from you soon.

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

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

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