Setting up a pharmaceutical cleaning strategy

Cleaning is an essential practice for any pharmaceutical activity. Difficulties can arise from the fact that the concept of ‘clean’ is not easily defined or can be related to non-evident residues.

 

Defining differences between sterilization and cleaning treatments, for example, is important to understand in-depth the main problems and peculiarities when setting up a cleaning strategy.

 

The kinetics of ordinary sterilization processes are well understood: to sterilize means to destroy or inactivate microorganisms. In this perspective, we know the target and we can define it in terms of a number (CFU/unit) and resistance (D, z). Though the definition of sterile product/ item is probabilistic (PNSU – Probability of Non-Sterile Unit or SAL – Sterility Assurance Level), it is universally accepted.

 

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, lubricants, microorganisms, etc. There is no absolute definition of cleanliness. The kinetics of the cleaning procedure are 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.

This is the reason why Fedegari have published a new e-book: to discuss the main challenges on taking the right decisions while developing a cleaning strategy. New requirements have been faced by manufacturers, new targets have been fixed and the evidence that these are met is shown through successful case studies. Our aim was to highlight the best practices and existing solutions to support your decision-making.

This is certainly a multidisciplinary issue that involves various company areas: from “Regulations” to Engineering, from Quality Control lab to Production department. Fedegari have collected contributions of all these areas together in order develop a robust and repeatable cleaning process.

In their new E-book you will find:

  • Aspects Distinguishing a Cleaning Process
  • Steps for Setting Up a Cleaning Procedure
  • Case Study I: Removal of Bacterial Endotoxins
  • Case Study II: Application of a Washer Sterilizer
  • Case Study III: Soil Removal From Smart Plate

 

Download it here for free. If you want to discuss your cleaning strategy with us give us a call at 800-829-5741.

 

 

FOWS The power of steam: a cost-effective cleaning

 

 

 

Fedegari Lab Division latest innovation is a Lab Glassware Washer that capitalizes the experience done with FOWS-series of washers in the pharmaceutical industry.

 

The new FGW Lab Glassware Washer uses a steam generator to improve washing performances: steam has an optimized emollient effect on greasy and sticky dirt.

Moreover the use of steam can significantly reduce operating costs: this true eco-friendly solution allows to minimize the need of detergents as well as water consumption, lowering the running costs per cycle. In addition, steam is able to access hard-to-reach areas and therefore clean thoroughly. A conductivity meter placed on the FGW drain is capable to detect the water purity, helping to terminate the process as soon as the desired set-point is reached thus further reducing water and other utilities consumption of the washer.

The cleaning process is constantly supervised:

  • Dedicated probes monitoring the temperature of the air/water and of the steam in chamber
  • A dedicated trasducer controls the pressure of the circulating water.

 

Fedegari Glassware Washer has an internal LED lamp that remains operative during the whole cycle: in case of alarm evident signals are displayed by color change.

 

The piping, as any other equipment manufactured by Fedegari, has a rigorous sanitary finishing. The machine is loaded by a modular rack which could be standard or customized for adapting to all loads configurations and is directly connected to the piping.

 

As all Fedegari laboratory process equipment, the FGW is easy to use specially thanks to ergonomic loading height, a friendly process controller and the interchangeable external trolleys compatible with Fedegari FOB5 lab sterilizers.

 

As all Fedegari lab equipment, the FGW series is compliant with cGLP standards.

The FGW series is equipped with Thema4lab process controller, engineered and pre-validated by Fedegari according to GAMP5. Thema4lab is the most advanced process controller for lab applications, based on a wide library of phase groups, developed by Fedegari thanks to its experience with the highest standards in the pharmaceutical industry.

Having doubts about the Thema4, please see this podcast we did a couple of months ago for our Lunch and Learn Webinar Series.

 

On demand you can also integrate the FGW Lab Glassware Washer with your FOB5 Horizontal Steam Sterilizer.

 

For more information on this or any other Fedegari products please give us a call 800-829-5741

Complete Production Line by Cozzoli

On specific client demand, Cozzoli has developed a complete production line that houses Filler, stopper, capper and unscrambler. The complete production line was installed at Biocor in Omaha, Nebraska. This is a very comprehensive production line solution since it meets all the FDA regulations regarding vaccines for veterinarian use.

 

OPERATIONAL LINE SEQUENCE:

Containers are placed on the unscrambling table, where they are automatically fed into the filler infeed conveyor. The containers are allowed into the filling station by a gating device, adjustable for different container sizes. After completion of the fill cycle, filled containers travel to the RS400 Stoppering Station, where full stopper insertion occurs. After stoppering, containers then travel to the CM200 Crimping Station, where aluminum crimp seals are adhered.

 

Containers enter the filling machine via the gating device and are filled using the diving nozzle system. The VR840 is a positive displacement liquid filler, operating on a 4″ pump stroke. This filler is equipped with a total of 8 stainless steel syringes for fill volumes up to 600 ml, and speeds up to 120 bottles per minute. After the fill is complete, containers cycle out of the filler and enter the Stoppering System.

 

BioCore’s RS200 Stoppering System is comprised of a vibratory sorting bowl, stopper feed chute, container feed screw and stoppper pressing foot. This machine is stoppering three container sizes with 20mm and 30mm stoppers. Sensors are located on the stopper chute for stopper make-up and on the conveyor for container make-up and back-up.

Traveling down the conveyor, the filled and stoppered vials are captured by an infeed starwheel for entry into the CM200 continuous motion rotary crimping machine. This machine also has a vibratory bowl; orienting the aluminum caps for placement into the feed chute. As the stoppered containers pass underneath, the containers strip-off the aluminum cap as it enters the infeed star wheel. The container then passes into the main star wheel, where the crimp head lowers. Contact with the cap activates the crimp head rollers to begin the progressive roll seal process.

CRIMPING OPERATIONAL SEQUENCE:

A fixed cup is used in each crimp head to prevent rotation of the container, and the crimping skirt height is easily adjusted for each size crimp. An automatic vial height adjustment is included with this machine for ease of container changeover. Simply place the container on the height gauge, and the height is measured and corrected automatically on the crimper. This machine will crimp 20 and 30 mm seals.

ACCUMULATION TABLES by Vetromeccanica

Accumulation is required in high speed production lines to make sure that the generating unit continues to run during malfunctions of downstream equipment.

Simply stated, if the generating unit is idle, the production is lost forever. Further, a certain amount of products or packages can be damaged during the stop and start cycles. Often manpower is utilized to unload product and then re-load the product back into the production flow.

A reliable accumulation system results in more production, less waste and decreased manpower. Vetromeccanica develops custom made solutions applicable to unique circumstances and production lines. The Accumulation Table utilizes a recirculating design that relieves back pressure, allowing for smooth, jam-free single filing of products through the discharge.

Vetromeccanica strives for limiting the footprint of the table which in their case is relatively small compared to the accumulation table’s storage capacity

If necessary Vetro can easily customize the standard accumulation setup to Bi-Directional Feed Table, that randomly discharges accumulation. Featuring automatic cycling, a sweep bar can be added to the system to provide automatic and complete unloading of product.

When a line stop occurs, the table’s belt is controlled to move at a right angle to the conveyor line, and begins loading. When downstream blockage is clear, the belt reverses for unloading thus making this solution best fit for unified packaging of different products. This conveyance solution is highly demanded within high level production lines that perform filling all kind of liquids into packaging in the chemical, pharmaceutical and food & beverage industries.

 

 

For more information regarding conveyance systems and accumulation tables please get in touch with us. 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.

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.

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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