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.

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.

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

LATEST DEVELOPMENTS: INTEGRATED SOLUTION FOR STERILE ANTIBIOTICS

Fedegari Group was chosen as the preferred supplier of contamination control systems for a multinational pharmaceutical company with a new sterile antibiotic powder plant. The main challenges of the customer were to optimize the powder filling process and benefit from the cost-effectiveness of process integration with the best ergonomic design for the operators as well as ensuring a reliable and safe pharmaceutical process.

 

Cost-effective Solution for Filling Al-kegs with Sterile Antibiotics

Fedegari Engineering Team has worked with the customer for developing the most efficient and reliable solution that would allow to fill the containers (kegs) in the safest way for the product and for the operators. The outcome is a complete plant that combines in a modular way various subsystems which have been individually tested by Fedegari for different applications thus minimizing the risks typically associated with novelties. The solution also represents the most compact design for this type of operations.

 

Filling Al-kegs with Sterile Antibiotics

Fig. 1 – Removing the Al-kegs from the washer rack

 

Fedegari was choosen as the only manufacturer able to supply the process equipment (Washer-sterilizer) integrated with RABS and surface bio-decontamination with hydrogen peroxide MAL (Material Air-Lock).

The Project

A Washer-sterilizer integrated with RABS and bio-decontamination with hydrogen peroxide MAL applied to the system. The washer unloads on module 2 – RABS.

Module 1: Washing-sterilization

Module 2: Washed kegs unloading station

Module 3: Empty kegs buffer station

Module 4: Manual powder dosing, capping and bagging with automatic pneumatic lifting device. Packaging materials and tools are introduced through the hydrogen peroxide MAL connected to the module.

Module 5: Filled and packed kegs unloading station

Thema4 process controller delivered to the customer will be completely integrated with SCADA system.

Cost-effective Solution for Sterile Antibiotic Powder Filling of Al- kegs

Integrated Solution for Sterile Antibiotic Powder Filling of Al- kegs

Cost-effectiveness & Results

This solution helped the customer to achieve the desired ergonomic results on manual operations reducing the risks of contamination due to the integration of different machines connected by the RABS into one unique system managed by a single process controller.

 

ERGONOMIC DESIGN – Unloading system designed to work at the same level (height) throughout all the modules – from the washer to the RABS.

 

SIGNIFICANT TIME AND COST-SAVINGS by easily handling the kegs through sequential workflow inside the RABS.

 

CUSTOMIZATION – Modular & custom-made loading racks

 

COST-EFFECTIVENESS – Time and cost-savings on training and maintenance due to standardization of components, procedures and process controller.

 

Cozzoli on the Science Channel show, How It’s Made!

Cozzoli’s Rotary Piston Filler was featured on the Science Channel show, How it’s Made. It’s an RPF12 Rotary Piston Filler/12 Head filling horseradish for our friends at Silver Spring Foods in Wisconsin.

 

 

Choose JVNW for Fermentation Processes

Whether you’re making small amounts of cider at home or large quantities commercially, one thing is clear: you’ll need food-grade vessels to ferment and age it in. Our food and beverage grade stainless steel vessels are the best solution for your fermentation processes.

For cider fermentation in our case, we offer the closed top, variable capacity and bottom cone fermentation tanks. The variable capacity tanks are great for cider makers who have varying amounts of product at a given time. The floating lid may be raised or lowered based on the volume.

JVNW’s fermentation tanks are designed to contain apple juice, to which yeasts are added in order to convert the sugars into alcohol and carbon dioxide. The fermentation process is temperature-controlled to ensure that it develops at the ideal temperature, thanks to special hollow spaces in the tank’s cylinder in which a low-temperature glycol solution circulates.

JVNW bottom cone fermentation tanks are designed for full yeast extraction, yeast settles in the cone and may then be reused in the following fermentation process.

Our steel tanks and vessels limit the odds for apple rotting during fermentation, thus excluding the chance for patulin contamination. Patulin is a toxic chemical produced from a number of moulds such as Penicillium and Aspergillus. Although apples tend to be the major source, any mouldy or rotten fruit could contain this toxin.

 

Why JVNW? Because our stainless steel systems undergo a series of tests in our mixer testing laboratory prior to shipping, which outs any chance for translational process deviation during fermentation processes.

 

In order to get the best out of your business, you have to work with the best in the business, JVNW!

PDA Journal of Pharmaceutical Science and Technology

Mr. Andrea Simonetti (Senior Manager, Strategic Initiatives at Bonfiglioli Engineering) and Mr. Filippo Amari (Continuous Improvement Manager at Novartis Vaccines) authored an article on presenting an unprecedented case study conducted on Pre-filled Syringes. This work is an example of excellent collaboration between the two companies.
The following link takes you to the article published on the 2015 January/February issue of PDA Journal of Pharmaceutical Science and Technology: http://journal.pda.org/content/69/1/108. If you need more information on this, please contact us.

The case study presented in this publication, investigated the capability of four CCI testing methods to detect simulated defects of different sizes and types on glass syringes, prefilled both with drug product intended for parenteral administration and sterile water. The drug product was a flu vaccine (Agrippal, by Novartis Vaccines, Siena, Italy). Vacuum Decay, Pharmacopoeial Dye Ingress Test, Novartis Specific Dye Ingress Test and High Voltage Leak Detection were, in succession, the methods involved in the comparative studies. The case study execution was preceded by the preparation of two independent sets of reference pre-filled syringes (PFS), classified, respectively, as examples of conforming to closure integrity requirements (Negative Controls) and as defective (Positive Controls).

Positive Controls were, in turn, split in six groups, three of which with holes laser-drilled through the PFS glass barrel, while the other three with capillary tubes embedded in the PFS plunger. These reference populations were then investigated by means of validated equipments used for CCI testing of the PFS commercial production; data were collected and analyzed to determine the detection rate and the percentage of false results. Results showed that Vacuum Decay method had the highest performance in terms of detection sensitivity and also ensured the best reliability and repeatability of measurements. An innovative technical solution, preventing possible PFS plunger movement during CCI testing execution, was presented as well.

 

Source: http://www.bonfiglioliengineering.com/news-events/460/pda-journal-of-pharmaceutical-science-and-technology.html

Aseptic Enclosures Case Study: Hospital Upgrades Cleanroom for a Fraction of the Cost and Time

Here’s a case study about a customer that saved a lot of time and money by implementing Aseptic Enclosures’ HEPACirc™ for their facility.

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Aseptic Enclosures’ HEPACirc™ is a general purpose, “Plug-and-Play” Clean Room Grade, air purification upgrade system ideally suited to many types of clean mechanical or processing work. It is designed to provide an ISO Class 5 (Class 100) or ISO Class 4 (Class 10) clean air environment suitable for cleanroom pharmacy, laboratory work, testing, manufacturing, inspection and/or pharmaceutical operations.  The built-in low wall return facilitates cleanroom compliance that could otherwise be impossible. An easy solution for those wanting to upgrade their existing rooms without the hassle of major construction. Custom sizes and configurations are available

 

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