The most versatile testing solution available

The SAIL is Bonfiglioli’s new automated inspection laboratory for different container types, sizes, and content bringing together CCIT, AVI and HGA technologies is an all-in-one machine that is suitable for in-process control, clinical trials, and laboratory use.

HIGHLIGHTS

 SAIL modular structure provides adequate flexibility upon all 3 of testing technologies:

– AVI (Automatic Visual Inspection)/ SAVI a collection of images is acquired using high resolution matrix cameras under designed illumination conditions.

– CCIT (Container Closure Integrity Testing) non-destructive integrity testing in packages by Vacuum Decay Method.

– HGA (Headspace Gas Analysis) inspection process is based on the Tunable Diode Laser Absorption Spectroscopy (TDLAS) method which accurately quantifies gaseous concentration levels.

• All in one Industry 4.0 based
   laboratory
• Ergonomic workstation
• Scientific and objective inspection
• 100% traceability
• Time & cost saving

SAIL modular structure provides adequate flexibility for all 3 testing technologies:

– AVI (Automatic Visual Inspection) /SAVI

– CCIT (Container Closure Integrity Testing)

– HGA (Headspace Gas Analysis)

The testing methods conform to current pharmaceutical regulations, such as FDA 21 CFR Part 11 and EU Annex 11USP General Chapter <790>ASTM F2338-09USP General Chapter <1207>EU Annex 15 and GMP requirements.

Contact our offices today to learn more about the SAIL.

CLEANING GUIDELINES VALVE ASSEMBLES AND SYRINGES

Regularly scheduled preventive maintenance minimizes downtime and assures trouble-free operation!M

Cozzoli’s exclusive sliding valve assemblies and precision honed syringes are mated for life and operate as matched sets on liquid fillers.

Each set is engraved with matching serial numbers that correspond accordingly. It’s important never to mix up or interchange designated serial numbers with other valves and syringes, as damage and poor operational permanence will result.

DISASSEMBLE AND ASSEMBLE

When disassembling, always withdraw the piston in a straight, horizontal line in reference to the valve or the syringe body.

Reverse this procedure to assemble.

Never use force, as it will cause the components to jam.

BEFORE USING

Before the initial use of valve assemblies and syringes, clean and rinse with a solution of soap and water, then flush thoroughly with clean water.

Place them on a lint-free cloth or paper.

Do not allow components to come in contact with contaminants or other metal parts after cleaning.

AFTER USING

Product should not be allowed to dry in the valves and syringes since it could cause them to score or seize.

Always disassemble them and clean properly with an appropriate solution that will remove product.

A bristle brush with a plastic center may be used. Blow dry components thoroughly to ensure that they are free of foreign particles and watermarks. When autoclaving, be sure that the piston is removed from the valve or syringe body.

WHILE IN OPERATION

Valves and syringes should never run dry while in operation. Either product or water must be present.

HANDLE WITH CARE

Proper valve and syringe handling is essential. Dropping, hammering on or restraining them in a vise may damage and render them inoperable.

PRIOR TO INSTALLATION

Check action of valve and piston within syringe cylinder to ensure smooth performance prior to installing on filler.

STORAGE

Between uses, valves and syringes to be stored wrapped in a lint-free cloth or paper.

This is necessary to avoid contamination and contact with other metal components.

Contact our offices to learn more about Cozzoli Machine Company and their comprehensive product line.

Table top Container Closure Integrity Tester

The LF-S11 by Bonfiglioli is a countertop compact machine, designed for Non-Invasive, Non-Destructive Container Closure Integrity Testing of diverse types of Pharmaceutical Containers filled with liquid, lyo, powders, etc..

Suitable for In-Process Control and Laboratory use without altering container and/or content features.

The integrated software system allows full compliance to provisions stated in FDA 21 CFR part 11 as well as EMA Annex 11.

3 Configurations of the machine available to meet all specific requirements:

– BASIC, for most of the container formats 

– XL, designed specifically for large formats (more than 100ml)

– SY, designed for syringes, carpoules including automatic plunger stopping device

Equipment test method complies with:

– FDA Guidance for Industry “Container and Closure System Integrity Testing in Lieu of Sterility Testing as a Component of the Stability Protocol for Sterile Products”.

– United States Pharmacopoeia General Chapter «1207» “Packaging Integrity Evaluation”.

– EU Guidelines to GMP Medicinal Products for Human and Veterinary Use – Annex 1 “Manufacture of Sterile Medicinal Products”.

– PDA Technical Report No. 27 “Pharmaceutical Package Integrity”

All dedicated test chambers are designed according to the container characteristics for a maximum of leak detection sensitivity and are monitored by specially developed electronics during the testing process. The group has been recently redesigned to obtain improved functionality (quick

 single-handed opening and closing). It is directly installed onto the Testing Chamber supporting flange and it is composed by: – A fixed bottom part; – A removable top cap (upper part) that allows plugging up the testing group corresponding to Container loading and unloading operations.

HOW IT WORKS

The test chamber fixed bottom part is equipped with a mobile piston, plunger stopping device (PSD), having vertical motion between two limit positions, “upper” and “lower”, and having a section equal to that of the PFS plunger.

The initial vacuum, generated in the test chamber, produces an upward movement of the PSD.

The same “upper” position is kept until the second reading; at that time, the action of a dedicated pneumatic actuator provides for exhaust of vacuum in the test chamber bottom area and produces the PSD downward movement towards the “lower” position.

For more information, please call our office and we’ll be happy to assist.

REVAMP YOUR OLD MACHINE FOR A NEW LIFE CYCLE

Did you know that your old machinery can be upgraded with the latest generation technology to increase machine life and achieve higher performance in terms of productivity, include remote access & increase autonomy of maintenance; all of this with no downtime?
Bonfiglioli Engineering, the worldwide leader in quality control solutions, continuously supports its clients to update their equipment with the most advanced solutions available in the field: JETS system.

JETS is a full-featured implementation of the Java SE platform, optimal for embedded systems. It offers many new features designed to improve functionality, accessibility, and reporting.
Here are the reasons why you should upgrade your machinery:

  • LONGER MACHINE LIFE 
  • REDUCED COSTS 
  • NO DOWNTIME 
  • AUTONOMY IN MAINTENANCE 
  • REMOTE ACCESS 
  • INDUSTRY 4.0 SYSTEM COMPLIANCY 

Only 5 working days for installation!
Customized maintenance contracts complete with worldwide dedicated technical services are also available to meet the specific customer’s requirements.
Discover the solution most suitable for you!

Contact us to receive your personal quotation by calling 800-829-5741

Cozzoli EXCLUSIVE OFFER!

Now until the end of 2018, take advantage of a 15% discount on parts and ensure your Cozzoli and MRM/Elgin machines are in peak condition!

A way to recondition an outdated machine, restoring it to optimum performance at a fraction of the cost and time of purchasing a new machine. We can perform small retrofits through whole overhauls either at your location or in our state of the art facility.

 

Offer Includes

  • 15% discount on parts
  • Discounts on preventative maintenance
  • Consultation service call comped when recommended action is taken

 

Cozzoli currently offers multiple maintenance packages:

  • Preventative maintenance with one time evaluation or regular scheduled inspections
  • Restorative maintenance including improvements, upgrades, wear part replacement and

parts repair or re-conditioning

  • Operational & maintenance training for new employees and refresher courses for

experienced technicians

 

Preventative Maintenance can help limit downtime. Contact us today to set up a one time evaluation or arrange regularly scheduled inspections to check the condition of your machinery.

 

Restorative Maintenance keeps your machines running at maximum efficiency. Our Tech Service Department can advise replacement of wear parts and recommend improvements and/or upgrades. Parts may also be sent in for an estimate of repair/reconditioning.

 

Cozzoli and MRM/Elgin Machines, also offer Operational & Maintenance Training for new employees and refresher courses for experienced technicians. We will provide your team specialized training on your Cozzoli and MRM/Elgin machinery.

 

Our Customer Service Department can schedule performance evaluations and help get you the best deal on commonly used machine parts.

Call 800-829-5741 for more information.

CONTAINER CLOSURE INTEGRITY TESTER

The LF-SMH by Bonfiglioli engineering is an offline multi head container closure integrity tester.

The Machine is suitable for laboratory applications, statistical purposes as well as off-line testing.

The Measurement System comprises applying a pressure differential into an airtight Testing Group enclosing the Container (Patent No. 1225063 of 13-9-1988). The test objective is to detect Container leakages by measuring the reached pressure level as well as the pressure change over test time.

The Measurement System follows the approved industry standard “ASTM F2338-09”

The Test method is a Recognised Consensus Standard by the United States Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), effective March 31, 2006

 

This machine is capable of testing up to 8 units per session and the complete cycle from start to finish is concluded in less than 90 seconds. The unique design of the machinery allows the users to handle multiple types of containers like Vials, Pouches, MDPI, MDI, IV Bags, Flowrapped Device, Bottles, Liquid Forms.

This machine is also capable of testing empty containers used for injection molded filling, filled containers whether they are closed, sealed or open.

Beside liquids, the LF-SMH can also perform tests on containers filled with powder or semi-solid content. This laboratory leak detection tester emphasizes the vacuum decay testing method which when operated at full speed in appropriate testing environment can perform up to 20 calculations per minute.

 

For more information regarding the LF-SMH or for other vacuum decay testing solutions please reach out to our product specialists at 800-829-5741

FGW: Free Standing Washers

The NEW Fedegari FGW is a glassware washer unit for laboratories, capable of performing a complete washing cycle composed of the following phases: pre-washing, washing, rinsing, acid/chemical additives rinsing, purified/DI water rinsing, drying and cooling.

Thanks to its dedicated process controller and to its special design that allows steam to be injected directly in the chamber, this machine is suitable for use in many different applications

Key Features
  • High level of programming and application flexibility with fully configurable cycles
  • Full traceability and documentation in order to meet the most stringent worldwide safety and quality standards
  • Sanitary components and CIP to ensure a perfect washing
  • Energy saving thanks to the use of steam and the recirculation of the water
  • Vertical automatic sliding doors, effortless pneumatically operated
  • Doors, chamber and piping components made of sanitary AISI 316L stainless steel
  • Ergonomic loading height
  • Built-in steam generator (0.5 bar)
  • Stainless steel (AISI 316L) modular internal rack with automatic connection to hydraulic circuit

Click here to see the product brochure, alternatively:

Contact us at  800-829-5741 for more info.

Fedegari Washing Solutions

Washer-Sterilisers (independent and combined use)

One of the most inovative solutions in the Fedegari washer range is also a unique and original. Combined Washer-Sterilisers have the ability to operate in three ways, they can be bought to be independent washing machines, operate as back up sterilisers when washing is not required or perform as a hybrid washer/sterilisers which allow you to wash, sterilise and dry machine parts, vessels and other materials in a single cycle.

 

Steam Washers

Fedegari high performance GMP Steam Washers capitalize on the experience acquired with the Combined Washer-Steriliser series within the pharmaceutical market. These machines represent a cost-effective solution for the highest performances. Fedegari steam washers use an integral steam generator to optimize performance and reduce operational costs. The state-of-the-art modular customizable rack can be adapted to every specific load configuration.

 

Free Standing Washers

The Fedegari laboratory glassware washer combines excellent washing and drying performances with first class materials, economical consumption, safety and operating ease. With its dedicated process controller and its integrated steam generator that allows steam injection directly in the chamber, this machine is suitable for use in many different applications.

 

Later this month we have prepared a special webinar broadcast with Fedegari that will focus on The Key Factors of an effective Pharmaceutical Cleaning Strategy.

For more information on the washing solutions by Fedegari, give us a call and we’ll be happy to assist you.

 

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

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