LSI Product specialist on tour in Wisconsin

We covered a lot of product related content on our Lunch and Learn Webinar series. Last week we unveiled a new product from Bonfiglioli Engineering that combines 3 different quality control machines into one compact block that is capable of doing Headspace Gas Analysis, leak detection & seal integrity testing and Visual inspection. Another product we demonstrated on the Lunch and Learn shows is the Pentafill Fill and Seal machine that is offered by LF of America. This machine comes with different ranges of productivity starting from 10 containers per load that are loaded manually and ranging up to 50 containers per load with the dual Pentafill A25 with automated loading and unloading cycles.

 

To get a better picture on the content that was delivered on the Lunch and Learn webstreams we recommend subscribing to our YouTube Channel and watching the content we broadcast every 3rd Wednesday of the month.

If you have any specific request or you want to set a meeting regarding any of the showcased products or for every other product from our manufacturer’s lines please get in touch and schedule a meeting. We are glad to inform you that our Pharmaceutical equipment expert team will be travelling to Wisconsin for a couple of meetings. Please give us a call at 800-829-5741 and inquire how we can fit you in the trip agenda.

Contract Packaging & Filling Made Easy

Contract Filling Service

LF of America contract filling service is performed onsite at their state of the art facility in Boca Raton FL. This service is performed using advanced contract filling machines for single dose plastic containers using injection molding technology.

This maximizes both production efficiency and product safety.

By using injection molding technology, we are able to fill packages on both small and large-size production scales without the added risk of overheating liquid products.

This is a significant advantage in comparison to traditional BFS machines, which use the unnecessarily risky, outdated Blow/ Fill/ Seal process.

 

Contract Packaging Services

LF offers contract packaging services that allow companies with liquid pharmaceuticals, OTC medications, health and beauty products, cosmetics, or other liquid products, the perfect container for full retail distribution. We specialize in a variety of different packages, vials, and containers, including unit-dose packaging systems, and even provide custom packaging manufacturing.

Product containers and vials should complement the products that they hold. This packaging, along with the label, is a form of marketing and will be the primary way consumers choose to purchase the item. Our contract packaging experts can help find the perfect container to reflect the image you wish to portray, including custom labeling, branding, embossing, and more.

 

Turnkey Solutions

LF of America provides our clients the option to discover the benefits of turnkey solutions. Rather than hiring separate contract fillers and packagers, turnkey solutions provide companies an affordable and efficient, all-in-one contract filling and packaging service.

Turnkey solutions are the best choice for companies looking to get the most out of their contract filling and packaging companies. Eco-friendly, scalable, and standard regulation compliant, the benefits of having a turnkey partner will save you money while giving you more time to focus on business operations.

Since turnkey solutions are quickly becoming the preferred choice for pharmaceutical companies and OTC packaging, it’s recommended to find a partner with experience and proven success. This is why we are proud to be the US-based contract filling and packaging company within the reputable Lameplast Group.

Contact us to learn about our contract filling and packaging services. For more information about sending in a small amount of your product to receive a free product sample, call 800-829-5741

 

TAMPER EVIDENT LABELLING SOLUTIONS

 

The Falsified Medicines Directive (FMD) 2011/62/EU will come in to force by February 2019. This directive requires two mandatory safety features that will enable medicines to be verified and authenticated along the supply chain:

  • Tamper evident features on the carton
  • A unique identifier (2D data matrix code and human readable information) on the carton

Newman’s range of automatic tamper evident labellers enables our customers to meet these new regulations, whilst also providing high levels of flexibility, quality and reliability. Designed to apply a range of self-adhesive tamperevident, anti-counterfeit and hologram labels, a single machine can handle a wide range of carton types and sizes without the need for change parts.

  • The CTE350 is a tamper-evident labeller that operates at speeds of up to 350 cartons per minute and, measuring just over 1m in length, is ideal for integrating in to lines where space is at a premium.
  • The CTE450 operates at speeds of up to 400 cartons per minute and, with track and trace serialisation capability, meets the requirements of the Falsified Medicines Directive.

Specifically designed for healthcare applications, the CTE350 and CTE450 have a stainless steel/GMP construction and are available with full Validation Documentation Package. In addition, Newman Labelling Systems is able to integrate different print and inspection systems to meet our customer’s specific requirements.

As a design and manufacturing company, Newman thrives on the challenges that our customers bring to us! If you have a specific labelling requirements then please let us know at 800-829-5741

AUTOMATED ISOLATOR WITH ROBOTIC ARM

It is no revelation to say that the age of robotics and automation is underway, as many assembly line industries have utilized production robots in one form or another for several decades. Yet pharma manufacturing remains heavily human. Robotic systems, however, can offer solutions to problems caused by the human element, such as the problem of microbial contamination in aseptic processes.

In a presentation at the Nov. 2014 PDA Parenterals conference in Munich, Germany, Sergio Mauri, Manager, Integrated Projects Business Unit, Fedegari Autoclavi, showcased his company’s gloveless, fully sealed isolator that uses a robotic, GMP-compliant arm. This solution is currently in an advanced development phase and the company hopes to market it for small-scale manufacturing of personalized, cytotoxic materials used for clinical trials.

 

If we are able to take personnel out from our process, then we will really reach the goal to have an advanced aseptic process,” he said. “The isolator with the GMP robot can give a flexible and modular solution.
He added, “Our system is based on a batch system and it is completely sealed.With no operator required, the isolator supports a completely automated fill/finish process. Without the need for gloves and the resulting glove ports and gauntlets, a greater level of sterility assurance is assured.

 

The equipment includes Wash in Place (WIP) capability to clean the contamination generated by the process. It also uses single-use material such as ready-to-use primary containers and closures, beta bags and disposal waste bags.

 

To ensure airtight construction, Fedegari’s seven-axis robot arm—built by robotics manufacturer Kawasaki—is stainless steel and designed to be low particle shedding. It is also resistant to high pressures and temperature wash downs, fully compatible for decontamination using H2O2 vapors. The system can also support both positive and negative pressures. An electronic motor controls the strength of the arm’s grip.

 

This is really a breakthrough,” emphasized Mauri.

 

External parts are decontaminated with steam sterilization. The tubs inside the isolator are decontaminated with H2O2 through a vaporizer that controls a dosing pump and heater for compressed air by means of saturated steam within the material transfer autoclave before entering the isolator.

 

Human Element Still a Factor

Fedegari, according to Mauri, is currently wrapping up development of the isolator. One company has already signed on to purchase the isolator and Mauri expects others to look into the system. He stressed that “nothing is advanced with human intervention,” and the company seeks to remove the human element from the aseptic environment except for loading and unloading the isolator.

 

Yet other industries have seen issues—and even crises—arise from becoming fully reliant on automation. In fact, overreliance on automated systems has been cited as a major factor in the 2009 crash of an Air France flight (1). In a separate interview with the PDA Letter, Mauri acknowledged this could be a potential risk. He said he would encourage a customer to use the Quality by Design approach to build a risk assessment regarding an operator’s ability to correctly respond to the equipment. It is part of training, part of making all the safety requirements in devices in order to avoid problems due to a lack of control by the operator,” he said.

 

While the isolator system is currently configured just for small-scale production, Mauri does see the potential for use in larger-scale manufacturing, particularly if manufacturers move to using smaller, parallel systems.

 

We have to take an example from semiconductor manufacturing where they have a huge manufacturing output by adding in parallel, smaller clusters. So, even if one of these clusters is running out of operation there are another 50 working giving out all the outputs. While in pharmaceutical manufacturing, with big-scale manufacturing we have a line, and if the line is jammed and it stops for two or three hours, you are losing the production of two or three hours,” he explained. “We have to learn from other businesses how to manage the efficiency of the pharmaceutical industry.

2018 Events & Exhibitions – Bonfiglioli Engineering

2018 Events & Exhibitions – Bonfiglioli Engineering

 

Bonfiglioli Engineering is looking forward to an eventful autumn!

Visit their Events & Exhibition updated page and don’t miss the opportunity to meet with their engineers:

– FARETE September 5-6, Bologna – ITALY

– FEA GLOBAL AEROSOL EVENT October 4-5, Dusseldorf – GERMANY

– PACK EXPO INTERNATIONAL October 14-17, Chicago – IL USA

– P-MEC INDIA December 12-14, Delhi NCR- INDIA

 

Do not hesitate to reach out and inquire about our booth locations and to request your access passes.

Vetromeccanica at Pack Expo

Vetromeccanica S.r.l. – Conveying Solutions Attending Pack Expo

 

Specialized in conveyors and accumulating tables for loose and packed containers, make sure to connect with Stefano who will provide details on their fleet of Conveying systems. VetroMeccanica also offers conveyors for products which require a specific and more tailored design.

Vetromeccanica Srl has been engineering and producing bottles conveyors since 1992.
Starting as a glass bottle conveyors manufacturer Vetromeccanica has been continuously extending its field of expertise and in the ’90 became one of the world leader manufacturers of air conveyors for PET bottles.
The company offers nowadays a comprehensive range of conveyors for both primary and secondary packaging. Conveyable products go from yoghurt cups to toothpaste tubes varying from beverage, food and chemical industry.

 

Stefano Lodi, Vetro Meccaninca Business Development Manager will be in Attendance. Contact Stefano beforehand to schedule a meeting and discuss projects concerning Vetro Meccanica product line by emailing him: s.lodi@vetromeccanica.it

 

Contact Stefano Lodi and set up a time and date for a meeting since his schedule is very tight.

 

If you want to discuss other conveying solutions that we can help out with, please call 800-829-5741 and let us know what we can do to help you out.

Labelling Systems: When is an Accessory a Necessity?

Labelling Systems: When is an Accessory a Necessity?

 

In its simplest format, a labelling system applies a label securely to a product or container; everyone understands this straightforward concept.

For example, in the food industry it could be a label that combines nutritional information with cosmetic appeal and branding to a can of beans. The label will include batch specific information such as ‘best before’ and ‘use-by’ date. It’s important the correct label is applied to the product and in such a way as to be readable and look good i.e. not skewed or creased.

 

In the pharmaceutical sector, the application of labels to products is more regulated. Apply the wrong label and a product might cause considerable harm or even death to the person mistakenly taking it. There can also be a lot of information to be included on a label for a pharmaceutical product yet the actual container is often small, resulting in a variety of different label types being used such as leaflet labels and hanging labels.

Lastly, labels for a single product will require different information, from a code per batch through to individual identification for each and every label; in many cases that information needs to be validated. The wrong information on the label can be a costly mistake and could be highly dangerous to consumers. It’s important that any labelling system is easy to use, reliable and ensures highquality application of labels.

However, where identification of a label is critical to an industry, as in the case of the pharmaceutical sector, then a basic labelling machine is not enough; system accessories will be required to meet the needs of that industry and its stringent regulations. ‘Accessories’ is almost a misleading term – these system add ons are often 100% essential – but I refer to them as such as these are selected in each case based on application requirements and customer preference. In such instances accessories aren’t there to ‘promote and decorate’ a container, but provide the critical identification of the contents of that container.

There are many labelling system accessories readily available that will enable you to comply with regulations and standards, provide security/validation throughout the labelling process and increase line efficiency. Which are suitable very much depends on the specific requirements of the application and the degree of automation required, so here I will look at the accessories that are available to meet these needs.

Not all labelling system manufacturers have the experience or skill set to help select and integrate these types of accessories. Newman Labelling Systems has extensive experience here. For example, we have been incorporating Vision Systems into our labelling machine for more than 25 years so we fully understand the strengths and weaknesses of these types of systems. Such manufacturers not only provide quality labelling systems, but also an added value service by recommending suitable accessories to meet needs and budget, whilst steering you clear of those that do not.

Call 800-829-5741 to inquire about our labelling accessories that might be essential for your production line.

Bottle Cap Torque Testing: Why is it Important?

Over time, the subjective feeling of cap tightness triggered the development of more reliable and consistent measurement devices, such as the spring based manual torque tester (analog). By the late 1980’s, ergonomic concerns and repeatability issues (such as varying cap gripping pressure and employee joint/muscle issues) lead to the development of manual (digital) and automated torque testers. Ever since, changes in materials, marketing themes, transportation methods and packaging aesthetics and processes (induction sealing, hot filling) have created new challenges and drives continuous product improvement on this field.

 

Why is Cap Torque Important?

Consumers judge bottled product quality based on many observations:

  1. The appearance of the package.
  2. The appearance, efficacy/taste of the product.
  3. The ease of opening and re-sealing the closure.

 

Brand owners, bottle cap/bottle suppliers are under tremendous pressure. They must:

  1. Reduce the cost of the packaging (lightweight, 1 vs 2 piece enclosures). – Lightweight bottles are pressurized to maintain product quality and package integrity. Insufficient torque and a resulting bad seal can reduce shelf life, cause product leaks, and the bottles can collapse when stacked in multiple rows. – Lightweight caps are more sensitive to over-torqueing. Over-torqued caps can develop cracks causing product spills and shelf life issues.
  2. Improve the shelf-life of the products (hot-filling, induction sealing). – The different thermal expansion contraction rates of the cap, liner and bottle materials, the varying dwell times between cap tightening and release torque measurements can all result in different release torque values. – Too much torque can cause wrinkles on the foil resulting in a bad seal, spills and reduced shelf life. If the threads strip, or the applied torque is too low, the foil will not be seated properly resulting in shorter shelf life.
  3. Maintain the quality of the product while innovating package design, improving aesthetics, ergonomics and security (tamper evident band, child-resistant design).

– Example: User configurable cap that can function both as Child-Resistant (CR) and nonCR closure. Such design increases QC requirements:

The torque must be monitored to maintain good induction seals.

The CR functionality (shelling/reverse ratchet/topload) needs to be controlled.

 

We have some tooling and machinery available for onsite demos. For more information or to schedule a visit please call 800-829-5741.

New Washing solutions brochure by Fedegari

Cleaning is an essential practice for any pharmaceutical activity. it is impossible to manufacture drugs in dirty conditions, even if soil is not evident. Defining differences between a sterilization and a cleaning treatment is important in order to understand in depth the main problems and peculiarities when defining a cleaning strategy. To sterilize means to destroy or inactivate microorganisms.

We know the target and we can define it in terms of a number (CFU/unit) and resistance (D, z). The definition of sterile product/ item (PNSU – Probability of Non-Sterile Unit or SAL – Sterility Assurance Level) is probabilistic but is universally accepted. The kinetics of ordinary sterilization processes are well understood. On the other hand, for a cleaning process, the “enemy” is not defined and in any case can vary on a case-by-case basis: residue of previously processed product, diluents, solvents, various chemicals, lubricants, generic soil, microorganisms, etc.

There is no absolute definition of cleanliness. The kinetics of the cleaning procedure is unknown. Consequently, also the definition of “cleaning dose” to be provided is undetermined. In these conditions, even regulatory bodies struggle. Essentially, they allow manufacturers considerable flexibility in establishing their own cleaning specifications. The FDA, for example, does not define methods describing how a cleaning process should be validated. FDA inspectors have to assess the rationale used to set the cleaning limits, making sure that their basis are scientifically justifiable and grounded on adequate knowledge of the materials involved.

 

Check out the new technical brochure HERE!

 

For any additional information please get in touch with us via email or by calling 800-829-5741

Filling Methods by Cozzoli machines

For almost a century, Cozzoli Machine Company has provided technologically advanced machinery for the packaging industry. Till today Cozzoli has developed a variety of filling methods to meet your production goals.

Cozzoli offers inline or rotary filling with piston, peristaltic pump, diaphragm pump or time pressure technology. Choose continuous or intermittent motion, stand alone or monoblock configuration. Every Cozzoli filler provides unmatched ease of container handling and change-over. Provided below are the different Filling Methods that can be carried out with Cozzoli filling machines.

 

Fill – to – Level

Fill-to-Level fillers are especially suited for thin and foamy products, like cleaning solutions for example. These fillers compensate for variations in container volume while retaining cosmetic fill accuracy. All of this fillers operate on the principles of gravity, pressure and vacuum.

 

Time Pressure

Time Pressure filling is accomplished by controlling the flow of the product through the tubing. By design, the product stays in the manifold that feeds the tubes. A computer calculates the product flow time needed based upon manifold pressure, nozzle size and target fill volume.

 

Piston Filling

The Piston fillers can have industrial and aseptic applications. Piston fillers are ideally suited for filling a diverse range of products. These fillers are ruggedly designed yet precisely built for long trouble free operation. The piston product viscosity range can be from 1 to 100K centipoises and with slight customization even above that.

 

Peristaltic Pump

Peristaltic pump is a system where nothing but the tube touches the fluid eliminating the risk of the pump contaminating the fluid or the fluid contaminating the pump. The complete closure of the hose, which is squeezed between a shoe and the track gives the pump its positive displacement action preventing backflow and eliminating the need for check valves when not in operation.

 

Diaphragm Pump

Diaphragm Pump fillers are suited for corrosive chemicals, abrasive materials and delicate liquids. These are also used with blood, insulin and plasma filling systems. The Diaphragm pump is a completely enclosed system that eliminates air bubbles on small fills and features accurate repeated fills.

 

Rotary Time Pressure

Time pressure fillers are well suited for filling heavy viscosity products. The nozzle is open to the product for a specified amount of time to achieve proper fill volume. Proper fill is dependent on three critical areas: time of fill, pressure of the flow and filling speed.

 

Vacuum Powder

This totally enclosed system removes the possibility of product contamination. Fill volume of each piston can be independently adjusted during operation. Two to sixteen stations are available. Multiple dose fills are ade possible by simply setting the preferences on the micro-processor. This also provide a solution to product loss due to dusting issues that is virtually eliminated.

 

Call 800-829-5741 to inquire about pricing and to obtain additional info on the different filling and pumping systems developed by Cozzoli.

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