Vol. 1, No. 5

March 2004

In This Issue:

INTERPHEX IS COMING UP!

VISIT US AT BOOTH #357

See the Newest Enhancements to Our FILAMATIC® Pharma Packaging Machinery Solutions

Interphex 2004 is coming up March 16-18 at the Javits Convention Center in New York. You're invited to stop by Booth #357 and let us treat you to a demonstration of our pharmaceutical packaging solutions. Or, let's discuss how we may be able to help you with your IQ/OQ validation requirements.

What's new at you ask?
You can see for yourself why our FILAMATIC® Bench-Top Filling Systems provide a reliable and cost-effective solution for your pharmaceutical, biopharmaceutical, and diagnostic small production needs. They handle a wide variety of products and viscosities in fill sizes ranging from less than 1 ml. to 1.1 liters per dispensing cycle at filling accuracies to ±0.5%.
There will also be an interactive multimedia demonstration of our customized Monobloc Packaging Systems, including the industry's first automated fill/finish packaging system for pre-capped/pre-sterilized microtubes. FILAMATIC® Pharmaceutical Monobloc Systems now offer functionality such as filling, fitment/plug insertion, stopper insertion, screw capping, and aluminum overcap crimping.
www.filamatic.com Website Update

Don't forget to check out our multimedia, interactive, www.filamatic.com website. Navigation tools, including pull-down menus and key word searching, allow visitors to readily access company and product line information organized by equipment/machinery type and customer industry. The website is continually updated with new information regarding our diversified line of FILAMATIC® packaging machinery. March's coming attractions include:

  • a webpage of frequently asked questions (FAQs),
  • information regarding FILAMATIC® integrated systems,
  • video of semi-automatic/ bench-top filling solutions
  • specifications for our automatic vial traying systems, and
  • video of molten products filling systems.

The "Press Releases" and "Newsletters" webpages, accessed via the "About Us" menu on our homepage, are noteworthy. The former provides a listing of and access to all press releases, typically new product information, issued by NIC after October 2002. The latter allows a website visitor to access all previous editions of NIC's "FOCUS on FILAMATIC®" eNewsletter.

You can even specify any one of a variety of liquid metering systems in order to dispense your product, regardless of its properties and characteristics, more accurately than ever before.

If you are in the biotechnology arena, you have to see the ground-breaking FILAMATIC® monobloc system for pre-capped/pre-sterilized microtubes. It's designed to sort and feed the containers using a vibratory feeder, remove the cap from each container, accurately dispense the required volume of liquid using a peristaltic filling system, reapply the cap

to the container, and discharge each completed microtube directly into an accumulation bin. You get all of these capabilities in a compact system (13 ft2 of floor space) that incorporates a unique GMP design, including a two-position operating station and an integral HEPA filtration system, to minimize the possibility of product contamination.

For more information, or to schedule an appointment at INTERPHEX with one of our systems consultants, contact:

Mary Burchard
National Instrument Company, Inc.
4119 Fordleigh Road
Baltimore, MD 21215 USA
Phone: (800) 526-1301 or
(410) 764-0900 -- ext. 229
Fax: 410-764-7719
e-mail: info@filamatic.com
www.filamatic.com

Our Customer Care Promise

Whether you work in the pharmaceutical, cosmetic, household products, chemical specialty, or food industries, you need a filling equipment resource you can count on.

In the design and engineering process, it means having someone who listens to your directions and delivers solutions that are exactly to specification, without costly add-ons you didn't want.

On the production line, it means the difference between consistently hitting your numbers and constantly playing catch up.

In training and technical support, it means having people who are always only a phone call away, 24/7.

That's the way you develop the close working relationships that make all of the effort rewarding.

When you work with us, we promise the following:

  • You will always speak with a knowledgeable, courteous staff member who will answer your questions and volunteer helpful information related to your topic.

  • You will always receive quick response to any inquiry.

  • You can expect to receive a thorough, yet timely response to an RFQ for a FILAMATIC® filling or monobloc system.

  • You will always get design solutions and recommendations that are focused entirely on your packaging requirements.

  • You will always have the support of our technical service and engineering personnel in identifying special parts and system components.

  • You will receive price quotes and delivery/availability information for FILAMATIC® spare parts in under five minutes. (For example: A typical telephone quotation, involving 4-5 part numbers, will only take approximately four minutes.)

  • Your spare parts order will be handled quickly while you are on the phone. (For example: Your phoned-in parts order containing 2-3 line items is entered in less than four minutes.)

  • Your order for in-stock parts will be shipped within 24 to 48 hours of order placement. Many orders are shipped the same day.

  • You can count on an on-time parts shipment success rate of 90% (and climbing).

  • Shipments will be securely packaged with the packing slip displayed on the outside of the shipping container for easy identification.

  • On all orders shipped via UPS, you will receive a post-shipment e-mail message that includes your tracking number.

Put us to the test. Bring us your toughest packaging application, technical questions, or parts request. If we don't exceed your expectations, we want to know because, at FILAMATIC®, the most important things we fill are our promises to you.

SPECIAL OFFERING

Contact Mary or Belén in our customer service department and mention the four-character alphanumeric code "DSA7", and you will receive a 10% discount, or a 5% additional discount, on bench-top filling systems (i.e. FILAMATIC® Model AB, AB-5, AB-8, DAB-5, or DAB-8 units) and spare parts ordered directly from NIC on or before April 2, 2004. A 10% discount will be applied to line items that do not otherwise qualify for any of NIC's standard quantity discounts. A 5% additional discount will be applied to those line items that do qualify for a quantity discount (i.e. four or more filling units and/or nozzles, six or more glass syringes used with FU-0 or FU-50 filling units, and 50 or more filling unit wear components). Maximum discount amount per customer account, during the term of this offer, is $500.00.
FAQs

Q: We have a FILAMATIC® Model AB-5 bench-top filler that was built in the early 1970’s. After many years of reliable service, the motor has died. Is a replacement motor for this machine available?
A: Typically, direct replacements for the motors originally installed in bench-top fillers that are more than ten years old are no longer available, but most of those machines can be retrofitted with a new motor and a corresponding electronic controller. However, given that the retrofitting of the new motor and controller requires some amount of at-assembly machining and re-wiring, the bench-top machine must be returned to our factory in Baltimore, MD for the procedure.

Q: My Model DAB-5 bench-top filler is blowing fuses and I would like to return it to NIC for repair. Will I be given a cost estimate before any repairs begin? What is the current labor rate for this type of repair work?
A: We always provide a cost estimate, including both parts and labor, before beginning the repair process. The current labor rate associated with repairs of this type is $90.00 an hour (or $1.50 per minute).

Q: We have a Model AB-8 filler and recently replaced its blown DC motor controller with a new one. However, the machine still does not run. What could be wrong now?
A: First, check the main fuse. It may have been blown along with, or subsequent to, the initial problem with the controller. If the problem is not in the main fuse, review the hardwire drawing that came with your parts/instructions manual to verify that all wire connections are proper. If the unit’s wiring is correct, make sure that the rectangular IR resistor is functional and properly plugged into the controller (when replacing a controller, the installation of a new IR resistor is recommended).

Q: The Teflon packing rings in our FILAMATIC® filling units seem to be wearing out quickly. Is there a way to convert the piston rod assemblies over to an o-ring seal?
A: Yes, o-ring adapters are available for most FILAMATIC® filling units. An o-ring adapter is easily retrofitted to an existing filling unit by following a procedure virtually identical to that for installing a new set of packing rings. Please contact our customer service department for pricing and availability.

If you have a question, or questions, that you would like to have addressed in the FAQ section of FOCUS on FILAMATIC, please forward it/them via e-mail to mcb@filamatic.com. Your question(s), and the associated answer(s), will be included in the next edition of this eNewsletter.

National Instrument Company Introduces Comprehensive, Customized Validation Packages to Help Customers Comply with Tougher FDA Regulations

National Instrument Company has introduced a new series of documentation packages to help its pharmaceutical and biotechnology customers maintain best industry practices amid the rising tide of regulatory activity. "We have structured these packages in a number of customizable configurations to offer our customers maximum flexibility in terms of both specification requirements and degree of external assistance. Our aim is to give our customers a way to comply fully with FDA regulations without having to turn to costly outside consultants," said Joshua F. Rosen, Manager of Strategic Planning.

Customers may choose to specify any or all of the packages NIC offers. Documentation packages can provide one or more blank protocols in a generic format, or contain detailed experiments and instructions designed and drafted by NIC technicians to support a customer's specific FILAMATIC® system.

FILAMATIC® documentation packages typically include Installation Qualification (IQ) and Operational Qualification (OQ) protocols. IQ protocols provide organized installation plans that are used after new machines have arrived at customers' facilities. FILAMATIC® OQ protocols provide organized plans for verifying the operational capabilities of the subsystems associated with newly installed units. Completed protocols provide customers with comprehensive archival data containing, among others, specifications of materials that will be run on the machinery, preventative maintenance regimens, control system documentation including PLC programs and logic diagrams, and verification that the systems interact properly with upstream and downstream process steps.

For the full text of this news release, click here.
National Instrument Company's Golden Anniversary Celebration

For more than fifty years, National Instrument Company has been a leader in designing and producing filling systems for the pharmaceutical, personal care, cosmetic, food, and chemical specialty industries.

To celebrate our Golden Anniversary, we are presenting a series of articles that trace the company's history from its origins in the basement of the founder's home to its position today as one of the most reliable and innovative filling-systems manufacturing organizations in America.

As we look back on the last five decades, we want to thank all our customers, friends and the hundreds of talented engineers, fabricators, salespeople, managers and administrators who have helped make NIC, not simply a great company, but a great family as well.

Part 2 -- The Next Generation

From 1950 to 1965, NIC's reputation as one of the top providers of bench-top piston fillers grew rapidly. Then in the late sixties, the company took the first steps to diversify its product line.

Working closely with customers, the company turned its considerable engineering and design capabilities to developing semi-automatic piston fillers that could be automated with conveyors, container indexers, and other add-on features. These enhancements transformed what has previously been a manually operated machine into one that was completely automatic.

The new era of diversification began in earnest in 1970 when Sidney Rosen's son, Robert, graduated from Drexel University, with a degree in commerce and engineering, and joined his father full-time at the company. At the time, the company was still exclusively a provider of liquid filling systems, primarily for the pharmaceutical industry. That changed as the seventies progressed. When NIC developed the ability to handle extremely thick materials such as mascara, liquids containing particulate matter such as salad dressings, and molten products such as stick deodorants and anti-perspirants, the cosmetic, food, and personal care industries took notice.

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Do you have any comments or suggestions regarding this eNewsletter or a specific feature of FOCUS on FILAMATIC? Please forward any comments or suggestions to Mark Bennett, or call 1-800-526-1301 extension 219.

©2004 National Instrument Company, Inc. All rights reserved (but feel free to copy it, post it, quote it, think about it, and forward it to others).

As the 1980's dawned, NIC faced a changing marketplace. One where customers were beginning to request integrated equipment such as multi-functional monoblocs, and single source responsibility for integrated production lines including fillers, cappers, and other packaging functions. Manufacturers, especially those in the pharmaceutical industry, looking to streamline their operations were outsourcing many of the packaging engineering functions that had previously been handled in-house.

Sidney and Robert decided the next major step in NIC's evolution would be to address the needs of the new marketplace by providing more comprehensive solutions to the manufacturing process. They turned to a veteran mechanical engineer named Don Lanigan to spearhead NIC's advance into the realm of integrated equipment by establishing the superior research and development capabilities needed to deliver the appropriate solutions and the technical support their customers needed.

In 1985, Don went to work and created a research and development facility on Long Island. Two years later, he decided it would be more productive if he moved to Baltimore. So Don set up shop in a newly constructed facility next to NIC's headquarters and assembled a staff of engineers and manufacturing system specialists to work under his guidance. He trained them in the design and manufacture of cappers and monoblocs.

Around this time, NIC also caught the filling industry's attention as one of the first companies to use servo drives in piston filling systems so that volume adjustments could be made on the fly to maintain optimum production efficiency. These new additions and enhancements to the product line served the growing needs of the company's customers, such as Abbott Laboratories, for integrated applications and created a launching pad for the next generation of FILAMATIC® technology.

The same customer-centric commitment that guided Sidney Rosen to found the company in the first place, once again played a critical role as the company re-tooled itself to meet the more diverse and complex demands of the marketplace in the last decade of the century.

In the Next Edition of FOCUS on FILAMATIC: New Strategies for a New Millenium