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.

Join Cozzoli at PACK EXPO 2018

 

We are pleased to announce Cozzoli Machine Company will host a breakfast meeting for our agents at Pack Expo International, October 14, 2018 at 8 am in our booth # S-1525.

Over a catered breakfast, we will review the machines we are exhibiting and discuss updates in resources and procedures at Cozzoli.

Please let us know if you can attend the breakfast meeting through email to John Bell at JBell@Cozzoli.com by September 28, 2018.

We look forward to seeing you at the agent breakfast meeting at Pack Expo 2018!

 

Stop by Booth # S-1252 and talk with members of the Cozzoli team including engineers, sales, technical service and management.

Torqo & SureTorque Upgrade & Trade-In Program

Mesa Laboratories, Inc. is offering significant trade in values toward the purchase of a new Torqo or SureTorque analyzer for:

  • Obsolete Torqo and SureTorque Models
  • Competitive Motorized Torque Analyzers
  • Competitive Manual Torque Testers

Why Upgrade ?
• While Mesa Labs provides best-in-class calibration & evaluation services for all Torqo and SureTorque units, repair services for the obsolete models may be impossible or expensive.
• Design innovation has been taken into account to improve the mechanics of measuring torque to provide customers with improved ergonomics, repeatability.
• Regulatory compliance support for FDA 21 CFR 210-211 & 820, USCPSC 16 CFR 1700, OSHA 29 CFR part 1910 and DOT 49 CFR 173, 178 regulations. Optional software to comply with 21 CFR part 11.
• Work with a more user-friendly touchscreen interface, reduce cycle time, take advantage of multiple communication options (Serial, USB, Ethernet).
• Improve compatibility with thin wall ROPP (Roll on pilfer proof) or plastic caps, smooth surface TEB (tamper evident band) closures, pouch, trigger spray, pump dispenser, child-resistant caps and uniquely shaped or lightweight bottles.
• Better support for existing and new test methods (release, closing/application, TEB, ROPP, strip, angle measurement and those listed in US Pharmacopeia Chapters 659, 661, 671, 1207, ISBT, ASTM standards)
• Add optional features to your torque analyzer, such as rotation monitoring, automatic product detection, digital topload monitoring, bottle clamping, closure gripping pressure monitoring, audio/visual alarm, full machine guard, etc.

Units Valid for Trade-In / Upgrade
• Legacy Torqo models (1502 & 1590)
• Legacy SureTorque models (ST-94, ST-100, ST-LAB, ST-120, BT-94, etc.)
• Competitive torque tester models

In order for the trade-in value to be applied on the quotation for a new unit, please provide the model number (i.e. 1502-30) as well as the serial number from the old analyzer.

We will ship the new machine and you simply return the old unit to Mesa Labs. Mesa will also provide the first annual verification / re-calibration and NIST traceable certification with every trade-in at 50% off current pricing.

The Torqo II+ and SureTorque analyzers include a full one-year warranty covering all parts and labor.

For more information on the Torque Trade-In Program or to request a quote, please dial 800-829-5741 to speak with a representative.

We look forward to continuing to serve the cap testing industry and our loyal customer base.

Headspace Gas Analysis for Parenteral Manufacturing

Headspace content verification is a solution to ensure parenteral product stability and sterility maintenance. Integrity defects as well as failures in the aseptic manufacturing process, including unexpected variability in the nitrogen flushing or vacuum application, pose a risk to the product quality and patient safety.

 

Monitoring the maintenance of container headspace conditions is needed for sterile drugs such as oxygen sensitive liquid products and lyophilized or powdered products. Any modification to the headspace pressure, moisture or oxygen level may result in product degradation, reduce of potency, shelf life and safety.

The cGMP even regulates specific aspects of production of sterile drugs that also requires that Containers sealed under vacuum should be tested for maintenance of that vacuum after a predetermined time period.

To satisfy this segment of the market, Bonfiglioli Engineering has developed multiple products that can continuously perform such content integrity verification processes. The Laser Cube is a non-destructive, non-invasive laser-based inspection technology for measuring the headspace level of gases, such as oxygen and carbon dioxide, as well as monitoring moisture levels.

The inspection method is created to meet specific customer requirements offering extreme stability and accuracy in inspection even where the headspace is limited. Bonfig Laser Cube is a compact and lightweight system that is easy to use and set up via integrated PC and any wireless touchscreen tablet. HGA inspection process is based on the Tunable Diode Laser Absorption Spectroscopy (TDLAS) method which uses a laser beam to detect the target molecules within container headspace. HGA is therefore ideal for the accurate investigation of:
•    Headspace conditions for products packaged under modified atmosphere
•    Closure integrity in pharmaceutical finished containers

 

For more information or to schedule a Demo please give us a call 800-829-5741

Celebrating 75 Years of Labelling Excellence!

This year is special for Newman Labelling systems as it marks their 75 years of specialized engineering excellence in the labelling industry. Newman Labelling Systems manufactures a complete range of high quality customizable labelling equipment to meet the specific demands of the pharmaceutical, veterinary, biotech, nutraceutical and other regulated industries world-wide.

Having built their reputation on quality, Newman Labelling machines are designed for fast, reliable and accurate application of both paper and clear pressure sensitive labels to a wide range of containers, including ampoules, vials, syringes, carpules, glass bottles, plastic bottles, square containers, securitainers and cartons.

Newman Labelling Systems manufactures a complete range of high quality, pressure sensitive labelling machines and systems designed for fast and accurate application of paper and clear pressure sensitive labels, including leaflets and extended text labels.

Coverage spans a wide range of container shapes and sizes used in pharmaceutical and related areas of container packaging including vials, ampoules, syringes, bottles and cartons.

 

Founded in 1943, this year marks a big milestone for Newman, being in operation for 75 years. For the US based clients, Newman has decided to proceed with special offers during this year’s Pack Expo in IL, in celebration on their anniversary.

Newman are committed to providing our customers with the highest quality solutions and support. For more info on the Newman Product line please do not hesitate to get in touch with us.

Bellow Bottles and Filling Machine

LF of America is a reputable designer and manufacturer of single-dose containers for pharmaceutical, personal care, and OTC liquid products. Our services provide the cosmetic and pharmaceutical industries with innovative packaging options and contract filling services, including full turnkey solutions. The Bellow Bottle container is one of our most functional container designs and is popular for its high number of diverse uses.

Bellow Bottles deliver practical solutions and are especially favored by health and beauty cosmetic products. Ease of application, various size options, and durable packaging materials all make the Bellow Bottle an exceptional advancement in the world of innovative packaging.

The Bellow Bottle is an ideal container for serums, creams, and even powders. LF provides options for both long and short cannulas and the Bellow Bottle container ranges in size from 3 mL – 9 mL.

Clients can customize their container by choosing between a variety of caps, applicators, and bellow bottle sizes, all available in virtually any color. State of the art manufacturing technology coupled with a world-class team of experienced packaging design specialists created a unique and proficient design we are proud to now bring to you, too.

 

Bellow Bottle Machine

We also have a second hand Bellow Bottle Filling Machine to offer. It was pre owned and used by LF of America. This machine is designed to not only fill our Bellow Bottles but can even be modified to handle a variety of other containers. The machine has the production capacity of filling up to 1,500 units per hour (or 25 units per minute).

 

Here’s how it works:

  1. A vibratory feeder sources the star wheel with Bellow Bottles.
  2. A second feeder moves the cap to the opposite end of the star wheel.
  3. The filling size ranges from as little as 2mm to 10mm.
  4. The filling process is done with a piston filling system.
  5. After capping, the filled units are loaded onto a conveyor.
  6. Containers can be coded on the bottom once loaded onto the conveyor.

 

Give us a call to learn more.

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

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