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.

 

 

Our Manufacturers Exhibiting at Pack Expo 2018

With its massive show floor full of machinery in action and packaging solutions for every industry imaginable, attending PACK EXPO International is an experience like none other.

This Year we have nearly all of the manufacturers we represent setting camp at PackExpo. Please take note of their Expo locations.

 

Cozzoli Machine Company will be exhibiting at PackExpo IL 2018.

As a single source provider for individual components to fully integrated lines, they offer production solutions for every application, from pharmaceutical, cosmetic, e-liquid, health, beauty aids, personal care, food and beverage, chemical, paint and industrial products. Featured machines on Cozzoli’s booth:

•       FPS2-SS
•       BMSV-6T-53
•       FSV50
•       IPF06
•       PF2-IS-176
•       F400X-SS
•       RPF8 ( Plus Additional Labeler and Unscrambler)

Stop by South Building Booth Number S 1525 to see our latest technology.

To set up a meeting, please contact Cozzoli at (732) 564-0400 or sales@cozzoli.com. We look forward to seeing you at the show!

 

 

LF of America will showcase their contract filling services.

LF offers unit-dose delivery systems for liquid solutions to the pharmaceutical, diagnostic, nutraceuticals, veterinary and personal care industries. LF of America (part of Lameplast) Group is a full service contract manufacturer for the pharmaceutical and personal care industries. Our services include packaging design and manufacturing, product manufacturing, contract filling of liquid solutions in ISO 8 cleanroom following GMP, filling and sealing machine manufacturing for our proprietary packaging.

The Center Piece at LF’s booth will be the Pentafill A25, a product that will be featured on our next Webinar set for 9/26.

See their machinery and get some packaging samples at West Building – W-879

 

 

Bonfiglioli Engineering will be setting camp at South Building – S – 1548

The main highlights of the BE booth will be the LaserCube and LF-S11, two tabletop devices designed for quality control of pharmaceutical containers:
The LF-S11 is a non-destructive, single-head leak testing machine suitable for laboratory applications, statistical purposes and off-line testing of pre-filled syringes, pouches, PFS nests, Monobloc, IV Bags, flow-wrapped devices, form fill seal and bow fill seal containers, carpules, bottles, ampoules and liquid form sachets.

With high levels of accuracy and stability, even in a limited headspace, the LaserCube is designed to meet the stringent regulatory requirements of the pharmaceutical industry. The unit also boasts a lightweight and compact design that is easy to use and set up via integrated PC and any wireless touchscreen tablet as the user interface.

To schedule a meeting on BE’s inspection machinery give us a call and we will let you know of the timeframes that are still open.

 

 

Mesa Labs will be exhibiting their vast array of Torque products.

Mesa Laboratories, Inc. Is a leading manufacturer and ISO 17025 accredited service provider of bottle cap torque testers and retorquers.

Mesa offers solutions from basic release torque testing of CT (continuous thread) closures to highly specialized testing applications such as:
– Low torque range (vials)
– Adjustable topload control (Child resistant caps and absolute application angle testing)
– Minimized topload (EDM and “floating” chuck options for TEB – tampe revident band – and strip torque testing, lose cap detection)
– Lightweight and gripping pressure sensitive closures (ROPP – roll-on pilfer proof designs)
– Pouch cap (requires application angle measurement and/or unique test methods)
– Dispenser and trigger pump caps
– Medical devices

Products that will be on display:

  • ST-120S
  • Torqo 1600
  • ST-H0X
  • ST-FT
  • Gold Bottle

Additionally MesaLabs will host In-Booth Education on the Variables in capping and Torque Testing.

Mesa Labs has extended the Torqo & SureTorque Upgrade & Trade-In Program. For more information on the Torque Trade-In Program or to request a quote, please dial 800-829-5741 to speak with a representative.

Come see Mesa Laboratories at Upper Lakeside Center – E-7025

 

 

Bahnson Environmental Specialties, LLC. is a leading Controlled Environmental Chamber Manufacturer.

Bahnson provides design, installation, service, & validation of standard or custom-built Walk-In Controlled Environmental Chambers for close tolerance temp/RH mainly to the pharmaceutical & research markets.
Applications include:
Walk-in Stability, HEPA Filtered Cold & Warm Rooms, laboratory/bulk storage, vaccine chambers, & high capacity -75°C Cascade low temperature storage and Biorepository chambers, in addition to standard incubators, warm rooms, cold rooms & freezers.
BES also has a complete line of ES2000 Reach-In Environmental and Photostability Chambers.

Come see Bahnson at Lower Lakeside Center – E-10930

 

 

Vetromeccanica is our first time exhibitor at the PackExpo.

They are specialized in conveying solutions for loose and packed containers for beverage industry but also for food industry, chemical industry. They design and manufacture tailor made solutions, turnkey systems and single modular components which meet high standards of quality and flexibility.

Their complete conveying line engineering service goes from plant layout to commissioning.

Conveying systems built by Vetromeccanica are in operation all around the world in most of the major bottle producers.
Vetromeccanica’s product line includes:
• Air conveyor for PET bottles
• Table-top vacuum conveyors
• Cartons and packs conveyors
• Pre-form and bottles bulk conveyors
• Bulk conveyors
• Bottles, jars, cups and cans conveyors
• Crates conveyors
• FIFO Dynamic accumulation tables
• Rotary accumulation table
• Spiral conveyors, Vertical conveyors, Rope conveyor, Tilting conveyor, Twist conveyor
• Dividers
• Drying tunnel

Meet Stefano Lodi, Vetro’s product specialist at Upper Lakeside Center – E-8528

 

 

Newman Labeling Systems

As a leading manufacturer of medium and high speed labeling systems for applying labels to containers and cartons typical to the pharmaceutical, veterinarian and healthcare industries, Newman meets cGMP standards and is compliant to all FDA requirements.
These Validated systems incorporate the latest technology meeting present and future demands (i.e., RFID complaint label applications, 21 CFR Part 11 compliant, ISO 9001:2008, ISPE member).
Newman’s family of competitively priced labeling machines are further supported by local parts and service organization and further complimented with a standard 3 year new machinery warranty.

Special Discounts on the models exhibited on their booth will be available for PackExpo Visitors.

Stop by their booth at South Building – S-4030 to see Newman’s comprehensive range of labeling solutions.

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

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.

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.

Interphex 2018

 

We are proud to announce the presence of our manufacturers to this years Interphex Expo that’s taking place this week at the Javits Center in New York City.

INTERPHEX has proven to be the place to find all of the State-of-the-Art Solutions you need to Cost Effectively Develop and Manufacture Quality Product. INTERPHEX is the premier pharmaceutical, biotechnology, and device development and manufacturing event where you can “Experience Science through Commercialization”

 

If you are planning on attending this tradeshow please take note of our manufacturers Booths and the equipment that they will be exhibiting on the show.

 

Bahnson Environmental Specialties, LLC. – Raleigh, NC
Presenting their complete line of Walk-In and Reach-In Controlled Environmental Chambers designed for diverse pharmaceutical applications including HEPA Filtered Cold Rooms, modular and traditional Clean Rooms, Stability Chambers exceeding ICH guidelines and high capacity -75°C Cascade low temperature storage chambers. BES will present information on 3  of their unique High Volume Freezer designs for the biorepository storage market that allow reduced dependence on small unitary freezers.

Come see Bahnson at Booth: 1945

 

LF of America, the US subsidiary of Lameplast group is going to exhibit at INTERPHEX 2018!

Lameplast Group is a worldwide leading manufacturer of plastic containers for the pharmaceutical and personal care industries. With more than 35 years of experience and a US branch located in Florida, the companies of Lameplast Group offer true turn-key solutions including the supplying of fully-automated semi-automated filling and sealing machines.

See their machinery and get some packaging samples at their BOOTH: 2364

Cozzoli Machine Company will be exhibiting at INTERPHEX 2018.

As a single source provider for individual components to fully integrated lines, they offer production solutions for every application, from pharmaceutical, cosmetic, e-liquid, health, beauty aids, personal care, food and beverage, chemical, paint and industrial products. Featured machines include the RPF8 Rotary Piston Filler, the FSV50 Mini Monoblock, the GW24 Ampule/Vial Batch Washer, and the PF2-IS powder filler. Cozzoli will also be showing their tabletop F400XSS Liquid Filler.

Stop by to see our latest technology in Booth 2805

To set up a booth meeting, please contact Cozzoli at (732) 564-0400 or sales@cozzoli.com. We look forward to seeing you at the show!

Claim a free pass for the exhibition HERE!

 

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!

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