Watson-Marlow Flexicon
 Aseptic filler offers universal design


 Watson-Marlow Flexicon's (Burlington, VT) "FPC50" universal filler, designed for injectable drugs, is now available with a restricted-access barrier system (RABS). The RABS incorporates filters that provide unidirectional airflow over the aseptic filling area.

Peter Lambert, the company's filling division manager, says a version of the filler is also available with a biosafety cabinet for processing potent drugs such as vaccines and cytotoxics.

A stable walking-beam mechanism enables fast changeover of vial sizes. Users don't need to order different format parts for the system, Lambert says. The compact machine's universal sorting bowl accepts all standard plugs and caps. The unit's peristaltic technology and disposable fluid path allow rapid product changeover. The device fills vial capacities from 2 to 100 mL and performs small to medium-size production runs.
 

HealthStar
 Unit fills quickly and accurately


 HealthStar (Braintree, MA) offers its "Purefil 1000" walking-beam flow-meter filler, which is adapted for clean filling environments in the pharmaceutical industry. The in-line machine fills as many as 300 containers/min. The device handles container sizes from small vials to 1-L units.

HealthStar designs and manufactures the filler's nozzles in house. Various nozzles are available to handle foamy, watery, and viscous products. The device incorporates magnetic flow meters that measure and disperse product. The meters ensure a filling accuracy of 0.25%. In addition, a sensor confirms the presence of a container before filling. 

The filler is completely servo-driven and features programmable logic control. Operators can program as many as 32 different batches into the machine. The filler can be cleaned in place, and changeover can be accomplished in 20–30 min.

Articles

PharmTech's monthly newsletter, reviews the Editor's Picks for the May 2008 edition: Watson-Marlow Flexicon and HealthStar

May 2008 Editor's Picks: Watson-Marlow Flexicon and HealthStar

Controlling modular, self-contained process skids (known as plug-and-play components) with an automation system can greatly increase a pharmaceutical manufacturing facility’s flexibility. This technique can help increase manufacturing process efficiency and allow operators to change process parameters easily. Establishing an automation system that communicates effectively with plug-and-play components can be difficult, however. 

 asked Scott Sommer, automation technology manager at Jacobs Engineering Group (Conshohocken, PA), about the challenges this automation solution poses and the strategies that can overcome them.

Q: Is it important for employees who design the automation system to understand the unit operation that each plug-and-play device performs?

A: My experience has shown that, as with any process-control system implementation, the best systems are those that were designed by professionals who truly understood the process. Structured, modular, reusable code requires that each function be modeled in the process-control system and that all interactions between these modules be allowed or disallowed based on the function of the skid. Unless the automation professional clearly understands not only what the skid can do, but also what it should not be allowed to do, the operation of the skid will be neither efficient nor error-free.

Q: How do you manage data flow to and from plug-and-play devices?

A: Mapping data (or associating data) to and from the process skid and managing the mapping configuration in the process-control system are two obstacles to efficient operation. Because the configuration and the actual skid data reside on different sides of the cable, close attention must be paid to the definition, implementation, and maintenance of the data link. Changes in logic must consider not only the affect on Skid A, but also on Skids B and C. If Skid D is introduced, then the number of possible interactions increases dramatically. A well-written and well-structured user-requirements document, functional specification, and software-design specification will help keep all components and data strategies in the foreground. These elements will provide valuable documentation of what exists in the logic and how it is structured.

Q: Why is it a problem if skids’ controllers follow different standards and templates than those of your plant system?

A: Obviously, standardization of data table space helps the identification and control of these skids. Standardization can be achieved through harmonization of the data structures with the skid vendor or through code that rearranges the data into the proper format and structure (i.e., forced harmonization or interpretation).

Q: How does a control system recognize a plug-and-play device?

A: It can do this in several ways. When each skid has a unique node or address, the control system can check for the presence of a particular input–output (I/O) rack or node.

Or the control system can use a smart transmitter tag (such as those from HART or Foundation Fieldbus) to determine which skid is plugged in. Usually a pressure-indicating transmitter works well because most skids in a pharmaceutical or biopharmaceutical plant have them. Alternatively, a skid could use a wireless transmitter to broadcast its identity.

Another solution is for operators to establish a keyed control-system connection. In this case, a particular pin on the connection or a special encoded input can be used to determine which skid is plugged in. No two skids would use the same key pin.

Once a skid is identified, its attributes, including which instruments are present and their corresponding tags, can be retrieved from a table or data file.

Q: Why is tagging and numbering skids difficult when you have several skids with different configurations that plug into a common location?

A: The main issue is that several devices might share the same connection to the process-control system. If chromatography skids A, B, and C can all plug into process location 1, then the control system will need to determine which skid is plugged into that location and what physical I/O corresponds to that skid.

Overcoming this difficulty requires allocating the same I/O table space for each of the possible skids that could plug into a single location. In addition, the same location should be assigned within that I/O space for each possible instrument (e.g., instruments that measure inlet temperature, outlet temperature, and pump discharge pressure), so that the same equipment modules and control modules can be used within the control-system logic. If a device does not exist for one skid, then its table space should be left open and unused.

Production Lines

Controlling modular, self-contained process skids (known as plug-and-play components) with an automation system can increase a pharmaceutical manufacturing facility?s flexibility.

Establishing Automated Control of Plug-and-Play Components

Life-science companies struggle to reduce their products’ total cost of quality (TCQ) and maintain high levels of regulatory compliance, product quality, and customer service. Several aspects of pharmaceutical operations such as regulatory compliance and validating manufacturing processes are often costly. Manufacturing products according to the process definition and within critical-to-quality (CTQ) values while documenting compliance also entails much expense. Manufacturers in the life sciences are increasingly implementing wireless technologies to reduce the overall cost of compliance.

Wireless technologies are not the same radio-frequency devices that were implemented in the 1980s for inventory management. Today, various wireless products are available. Companies are applying these products in innovative ways and, in some cases, achieving large cost savings. Most recently, manufacturers have successfully applied wireless process transmitters and wireless instrumentation to controls and distributed control systems (DCS) solutions that address validation and safety concerns. 

For example, one company had to validate and continuously monitor critical quality parameters in an alcohol tank farm. Because of the concentration of the liquid, the environment was harmful to standard, hard-wired instrumentation. The environment also presented safety and health hazards to the personnel performing the validation and monitoring.

The company deployed wireless-based process instrumentation to continuously monitor the temperature, pressure, volume, and specific gravity of the fluid in the tank. Connecting wireless instrumentation to the tank farm’s DCS reduced the cost of validation by 50% and the overall cost of continuous monitoring by 30%. This arrangement also shielded plant personnel from the safety hazards.

Together with web-based manufacturing controls and systems, wireless technology helps manufacturing and quality personnel operate equipment remotely. This flexibility is achieved using various mobile wireless terminals (e.g., palm devices), pentablets (i.e., handheld computers such as Motion Computing’s “F5” tablet), and convertibles (i.e., laptops such as Panasonic’s rugged “Toughbook” device).

Often, paper-based validation protocols may be adulterated with chemicals and process materials when initiated and completed near process equipment. In some cases, portions of the paper protocol are lost or destroyed, and the protocol must be executed again. But paperless engineering protocols can be initiated at the point of validation. In a paperless approach, the protocols are initiated electronically to capture the execution data and signatures at the point of validation. Rugged wireless terminals manage the electronic protocol. For life-science companies that adopt this approach, the cost savings associated with validation are significant. 

A major factor that increases TCQ is the cost to document evidence of manufacturing compliance. Many life-science companies are moving to a paperless batch record that enforces execution decisions and workflow during manufacturing. Using rugged wireless terminals in manufacturing to capture documented evidence where events occur is an easy way to establish a paperless EBR (electronic batch record). The EBR becomes the foundation for a release-by-exception strategy and results in significant savings in overall TCQ. 

Data security is critically important to life-science companies. It must be investigated by manufacturers who are considering wireless technology. Wireless transmission makes it easier for unauthorized people to intercept sensitive data. Encryption is the only way to protect data. Because security is such a significant concern to life-science companies, companies such as Cisco Systems (San Jose, CA) are aggressively seeking to embed encryption directly into their wireless technology.

In conclusion, adopting wireless process instrumentation and wireless terminal technology for pharmaceutical manufacturing directly leads to efficient process and equipment validation, consistent manufacturing compliance, improved safety for plant personnel, and an overall reduction in TCQ.

Mike Power is a life-science supply-chain manager at BearingPoint (Mclean, VA)

In the Mixer

Manufacturers in the life sciences are increasingly implementing wireless technologies to reduce the overall cost of compliance.

Equipment and Processing Report-05-21-2008

May 2008 Editor's Picks: Watson-Marlow Flexicon and HealthStar

Establishing Automated Control of Plug-and-Play Components

Wireless Technology Reduces Compliance Costs