About Marko

The PackExpo International has started!

The PackExpo International started today! Stop by booth # W-879 to meet LF of America and their Business Development Director Diego Bulgarelli. On LF’s booth you’ll have the opportunity to meet Lameplast Product Specialist that have bolstered LF’s Pack Expo team. They’ve also brought a fully operational Pentafill A25 fill and seal machine and can perform sample fills on site.

If you are attending the Pack Expo, make sure to stop by booth S-1525. Cozzoli are All set and ready to discuss their extensive product line with you or your engineers. Cozzoli are represented by their marketing department accompanied by the product developers and the engineering section. Cozzoli’s booth is laid out in a particular way so you can see every piece of machinery that they’ve displayed on their booth.

It’s the first day of Pack Expo in Chicago and we’re up and running! Meet the Newman team on booth S-4030 where you can see the CTE 450 in operation. On Newman’s booth you can also get a free sample of their standard print on labels as well as have the opportunity to network with one of the most comprehensive experts when it comes to tamper evident labels.

Vetromeccanica’s several product specialists and sales representatives are attending the Pack Expo and are stationed at Booth E 8528. Stop by their booth in order to learn about the latest conveyance solution and conveyor technology. They are also starting to build solutions that can be embedded onto existing production lines, connecting several machines assuring the most efficient productivity attainable.

Their custom conveyance solutions have been installed in many production lines across 5 continents in the food, beverage, pharmaceutical, chemical, dairy and secondary packing industries.

Visit Bonfiglioli Engineering at booth S-1548 and don’t miss the opportunity to meet their team while assisting to a live demo of two lab-scale machines from our leak testing equipment.

 

For further assistance please reach out to our project engineer that is in attendance. MaryBeth Eyer can be reached via marybeth@lsi1.com or 217-825-8110. 

 

We look forward to meeting you in Chicago!

Container Closure Integrity Testing Method Development and Validation for Prefilled Syringes

Utilization of prefilled syringes as a preferred container closure system for biologics has been increasing [1]. As a primary container closure system, prefilled syringes must provide an integral barrier that protects drug product stability and sterility throughout its entire shelf life. Drug manufacturers are required to check and demonstrate the system is capable of maintaining its microbial barrier integrity [2, 3]. In 2008, FDA further promoted container and closure system integrity (CCI) testing as a component of the stability protocol for sterile products

In response to the increasing regulatory expectations, the pharmaceutical industry has driven and witnessed significant technical advancements in CCI testing [5]. Instrumentation-based technologies, such as high voltage leak detection (HVLD) [6], vacuum/ pressure decay [7], mass extraction [8], and tracer gas detection (helium, oxygen etc.) [9, 10], have emerged and demonstrated improved detection capabilities compared to conventional dye and microbial ingress methods. Many of the technologies have been used for on-line 100% inspection and/or drug product stability CCI testing. In this article, we highlight our current thinking in an attempt to devise a systematic approach for CCI testing method selection, development, and validation.

General Considerations

In order to function both as a container closure system and as a drug delivery device, prefilled syringes feature many unique design elements. They usually include multiple containment compartments that are sealed by numerous interfaces. For example, the current stake needle glass syringes (Figure 1) provide a syringe barrel compartment for drug product containment and a separate needle shield compartment for needle protection. The syringe barrel compartment is sealed by the plunger on one end and by the needle on the other with the needle tip embedded in the needle shield. The needle shield compartment, sealed by the syringe barrel head,protects the needle exterior surfaces from potential contamination. The potential failure modes associated with each compartment and seal interface need to be identifi ed, assessed, and taken into account during CCI testing method development.

“In order to function both as a container closure system and as a drug delivery device, prefilled syringes feature many unique design elements.“

Furthermore, the plunger in a prefilled syringe is allowed to move within a range along the syringe barrel. When experiencing lower pressure environment during shipping and distribution, plunger movements in response to pressure variations may potentially aff ect seal integrity. Therefore, it is essential to evaluate plunger seal integrity following these special conditions.

In addition to the complex designs of prefilled syringes, the drug products packaged therein should also be considered. For example, prefilled syringes have been widely used for biologics, some of which could require extremely low temperature storage (e.g. -70°C). Since seal property of syringe components, especially elastomers (e.g. needle shields and plungers), is temperature dependent, CCI testing under extremely low temperatures could be required if theoretical justifications based on elastomer property are not adequate [11]. Moreover, drug-package interactions may impact method sensitivity and selection. For example, proteinaceous products could prevent mass transfer through CCI defects and reduce the sensitivity of a vacuum decay method [12].

Figure 1. Illustration of a stake needle glass syringe

CCI testing strategy for development

Many distinct CCI failure modes can occur throughout the life cycle of a syringe, ranging from component manufacturing, drug product filling and sealing, device assembling and packaging, to subsequent distribution and storage. It is essential to develop an overarching strategy to apply a series of CCI testing throughout the entire syringe life cycle.

CCI testing strategy development started with thorough understanding of syringe construction, design, and manufacturing processes. The CCI failure modes and eff ects associated with each aspect were first identifi ed. Using a risk-based approach, we further determined whether CCI testing is required, and if so, the intended uses and testing frequencies needed. For example, knowing the needle shield compartment seal integrity was tested by the component supplier, we elected to apply a non-routine CCI test to confirm its seal integrity upon drug product filling and sealing, and upon being assembled into devices. In contrast, for the product-containing syringe barrel compartment, we incorporated an extensive set of CCI tests into the entire product development cycle, including initial design confirmation, machinability studies, and product stability testing, to ensure CCI was achieved and well maintained.

Method selection

Table 1 lists the major CCI testing technologies available for prefilled syringes and their key characteristics. Note all the technologies have major limitations. When selecting appropriate methods, the following key aspects should be considered.

  • Suitable for its intended use. The selected method(s) must be suitable for the intended use and scope of a specific CCI test. For example, microbial ingress testing, although a good selection for media-filled syringes for fil lling process validation, cannot be used for stability testing because it does not apply to drug product filled samples. If a single method cannot meet all the testing needs, complementary methods may be applied in tandem to achieve definitive and comprehensive testing conclusions.
  • Applicable to the specific drug product-package. As previously mentioned, drug products can interact with CCI defects in various ways and may further aff ect the eff ectiveness of CCI testing methods. The method applicability to the specic product-package must be evaluated and adequately demonstrated.
  • Detection capability and eff ectiveness. Recent technologies utilizing mass extraction [8], HVLD [5], vacuum decay [7], have demonstrated reliable detection of CCI defects of 5-10 microns or smaller. These technologies are based on quantitative measurement of certain sample characteristics that can be further correlated to presence and/or sizes of CCI defects. The superior sensitivity and reliability made them preferred CCI testing methods over conventional dye or microbial ingress tests.
  • Non-destructive CCI testing. Non-destructive methods enable 100% CCI testing. In addition, they allow for further analysis of the failure modes and root causes, which in-turn provides valuable feedback for continuous improvement.

Method development

Upon establishing a preliminary method following vendor’s recommendations or literature search, we further focused on optimizing testing parameters and determining the appropriate pass/fail threshold.

Optimize Testing Parameters

First, various defect standards of known sizes (Table 2) were tested along with intact samples under different testing parameters. The correlations were thoroughly explored between key method parameters and instrument responses to intact and defect samples, aiming to identify a set of parameters that yield optimized separation between defect and intact samples (i.e. signal-to-noise ratio).

Refine Pass/Fail Threshold

To establish the preliminary pass/fail threshold, the optimized method was used to test multiple lots of filled intact syringes representing relevant product variations, including various packaging component sources/lots, drug products batches, as well as packaging sites and lines. The testing results were statistically evaluated to define the instrument baseline and variation (σ) for intact samples. Ideally, the pass/fail threshold should be at 10σ above baseline (i.e. above limit of quantitation LOQ). Defect standards of known sizes were then tested to further finalize and verify the pass/fail threshold. In cases where the 10σ threshold did not provide the desired sensitivity (as illustrated in Figure 2), the threshold setting was further adjusted between 3σ above baseline (i.e. limit of detection LOD) and the 10σ LOQ to achieve the desired detection sensitivity while keeping false positive detection probability (i.e. intact sampled detected as Fails) within the acceptable level.

Verify Method Effectiveness

Although defect standards are essential for initial method definition and optimization, they do not necessarily fully represent natural CCI defects. Natural CCI defects are of a large variety and most of them are not simple orifices or tubes. Therefore, the method performance was further evaluated using “real-world” CCI defects.

A good “real-world” defect sample set should represent all major probable CCI failure modes. Actual CCI defects could be obtained from various sources, such as reject samples from incoming or inprocess controls. When actual defect samples were not available for a specific failure mode and defect type, simulated defects were used.

A few iterations of the steps above may be needed to finalize the method. For methods used for stability testing, additional studies were performed to verify the methods are capable of detecting “aged” samples. Usually it was demonstrated by placing a set of productfilled samples with known defects on a stability study and testing the defect samples at various time points.

Method validation

Table 1. Characteristics of Major CCI Testing Methods

Table 2. Commonly-used CCI Defect Standards

In general, ICH analytical method validation guideline [14] was followed to validate instrument-based CCI testing methods. The key method characteristics, such as detection limit, range, accuracy, precision and robustness, were evaluated and demonstrated during the validation stage. In order to demonstrate detection capability in size, micro-pipettes, microtubes, and laser drilled standards of known sizes were usually used, which also allowed direct comparison of testing capability of various methods.

CCI testing methods were validated for the specific drug productpackage. Because the drug product formulation and package design may change during early development phases, a phase-appropriate approach was implemented to validate methods in concert with product development phases. For example, we utilized scientifically sound methods to support packaging system qualification and development stability studies. Once the product formulation and packaging design were finalized, the methods were then fully validated in support of primary stability and process validation CCI testing. Additional long-term method robustness may be further validated prior to implementing the method in QC laboratories for routine testing.

Figure 2. Approach to establishing Pass-Fail threshold

Summary

Appropriately selected and validated methods are essential for demonstrating container closure integrity during package and drug product development and manufacturing. However, it should be realized that current CCI testing technologies do not off er an ideal method that satisfy all prefilled syringe CCI testing needs. An integrated approach incorporating CCI testing and other engineering and administrative controls must be taken to ensure overall container closure integrity.

 

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.

 

JVNW is now ICC Northwest

We are excited to announce that the #ICC group, headquartered in St. Louis, MO, has stepped in to take over operations of JV NW in Canby, OR. JVNW is now conducting business as a new company: ICC Northwest.

ICC Group is a professional provider of engineering and design-build services for process related industrial clients. ICC provides an expansive portfolio of services, including Automation, Smart 3D design, Green Field Construction and Capacity Expansion for process-driven industrial clients. Additionally, ICC designs, installs and integrates CO2 Recovery Systems. ICC designed and built the Balcones distillery in Texas, the Templeton Rye distillery in Iowa, and have been contracted by Craft Brew Alliance to design-build and is now building the Kona brewery in Hawaii.

ICC’s entrance allows JV NW’s legacy to live on to accomplish an even bigger vision, explore cutting-edge technologies, and offering full engineering packages that will directly benefit clients, their business pursuits, and their bottom line.

ICC has also retained all of JV NW’s trusted, dedicated, and skilled employees as they are the backbone of our industry and are hiring more to serve our clients in a timely fashion.

Our focus now is on starting this new chapter of serving the industry by delivering the highest quality product, creating better opportunities for our employees, being a great partner to our suppliers, and supporting the local community.

For any requests and inquiries for ICC products and services, Please give us a call and we’ll be happ to assist.

Bahnson Environmental Specialties Products and Services

Bahnson Environmental Specialties offers a large selection of environmental chambers with proven quality construction and innovative technology, serving a variety of industries.

Temperatures range as low as -84°C (-120°F) with high temperatures to +350°C (+662°F) and humidity ranges from 10% to 98% RH.

Test chamber sizes That BES produces, range from small benchtop chambers for testing small components to full walk-in/drive-in rooms large enough to accommodate a semi-truck and trailer or larger, suitable for more comprehensive storage needs.

BES offers a complete line of temperature and humidity control solutions for today’s demanding research needs. These units combine reliable performance with a range of advanced features that make them a superior choice for a diverse array of applications.

BES offerings include:

  • WRST
    Optimum uniformity for cold and warm stability chamber studies
  • WRS Series
    A single chamber, a wide range of testing conditions
  • CRS Series
    Low-temperature precision and dependability
  • FAS Series
    Exceptional cleanroom capabilities with optimum temperature and humidity control
  • DRS Series
    Dry rooms tailored for specific pharmaceutical and industrial applications
  • LT Series
    Ultra-low temperature, high-volume freezers
  • ES2000 Series
    Reach-in chambers for your low-volume pharmaceutical and industrial test applications

 

Bahnson Environmental Specialties offers intensive preventive maintenance and calibration programs for most major brands of laboratory equipment, including environmental chambers.

Call us today and let us tailor a program designed to satisfy your complex equipment needs and demanding schedules.

Dryer designed and built by VETROMECCANICA

EOLO DRY is a drying system designed and built by VETROMECCANICA S.R.L.

 

EOLO DRY is characterized by a manual adjustment system of the air blades that allows the ideal positioning for any format (bottle or can) and also for the neck. This drying system allows to obtain optimal results in the various phases and types of labeling, sealing and coding.

EOLO DRY is composed of blowers that feed the specifically designed manifolds to obtain the right balance between pressure, flow rate and temperature of the air that is warmed up by the compression.

The Eolo Dry System is AVAILABLE IN:

  • MODULAR SYSTEM
  • STAND-ALONE SYSTEM

 

MAIN CHARACTERISTICS of the EOLO DRY:

  • AISI304 STAINLESS STEEL STRUCTURE with polycarbonate opening doors
  • MODULAR SYSTEM: quick & easy installation on pre-existing lines
  • HIGH EFFICIENCY LATERAL CHANNEL MOTORS

§  4 ADJUSTMENTS TYPES OF THE AIR BLADES by: ·        DEPTH, ·        HEIGHT, ·        LONGITUDINAL INCLINATION, ·        BLADE INCLINATION

  • ANODIZED ALUMINUM AIR BLADES: aluminum treatment that assures lifelong guarantee of the blades
  • INVERTER ON EVERY BLOWER: allowing to optimization of the speed of the air leaving the blades according to needs of the product that’s supposed to be dried
  • ENERGY CONSUMPTION OPTIMIZATION
  • Waste water and drop collection
  • NOISE LEVEL COMPLIES WITH SAFETY RULES
  • COMPLIES WITH EC REGULATIONS, NEMA and CSA

 

Technical data:

 

Here is a video demonstration of the Dryer system

https://www.youtube.com/watch?v=xv–10AuUr0

 

For more information regarding the EOLO Dry systems please call our HQ at 800-829-5741

How to Properly Calibrate Your Torque Analyzer

 

Cap torque analyzers are an extremely refined set of products that need to be cared for and calibrated on a regular basis to ensure accurate and consistent results. Calibrating these complex machines can be an intimidating process, however there are tried and true steps to follow to improve not only the calibration process, but also the end results.

Why is calibration important?

Regular calibration ensures that you’re getting the most accurate results which can greatly improve your ROI and avoid production loss and costly recalls. We recommend calibration be performed at least every 12 months.

 

The Five steps to calibrate your torque machine include:

  1. Before beginning calibration, be sure to attach the frame with 1-2 screws to ensure stability.
  2. Insert the pulley into the chuck and rotate the chuck. Make sure the screw is facing a direction that allows the wire to twist 90 degrees and lock the shaft.
  3. “Zero out” any offset and hang the weight slowly and deliberately.
  4. Make sure the weights are still and are not touching anything.
  5. Be sure to calibrate both sides of the machine. This will give you the proper torque read out.

 

To make sure you are consistently getting the most accurate results from your SureTorque products, Mesa Labs recommends yearly calibrations.

To meet your needs, we currently offer 3 different ways to manage your calibration:

  1. On-site calibrations
  2. Send your lab equipment to us
  3. Laboratory calibration kit

Call our offices now to inquire about Mesa’s calibration services.

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.

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.

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