Warehouse solutions include both the software and hardware used to ensure accuracy of inventory and organization of product services, such as shipping, receiving, inventory management, product or service layout, staff, bins, and purchasing. Having the right software in place is an integral component to a pharmaceutical organization’s supply chain and is crucial to the success of overall business processes. Appropriate software simplifies inventory processing through automation, thus ensuring tight control and lot tracking at all levels of warehouse management, and meets pharmaceutical industry-specific regulations and institutional requirements. Although software and the overall warehouse management solution (WMS) are crucial tools, common mistakes can make it challenging to maintain a successful warehouse operation even when these tools are being used. Common problems include failure to put in place an efficient warehouse layout best suited to the products being handled, lack of knowledge of the inventory on hand, and inadequate preparation and training of personnel.     

It may sound like a simple concept, but having a logical warehouse layout is paramount to the success of any warehouse solution. Think of a warehouse like an architectural blueprint—an easy-to-navigate system where each section is clearly defined. Most warehouses store product materials in bins that are often scattered throughout the warehouse floor area, which makes it challenging to find where certain products are located and causes delays and errors in product shipment. To avoid this, companies can establish a naming convention for bins so warehouse staff can find things quickly and easily, thus creating a logical sequence to bring people to where they need to be. Name the bins and layout the warehouse in such a way that when someone looks at a bin tag, they will know how to find the bin.

How well you and your staff know your products and inventory on hand will also help determine the warehouse layout and ultimate success of warehouse software. Place higher moving products near picking lanes that are close to shipping areas, place bulk areas in a location to facilitate bin replenishment, and determine logical areas for items that require cage, cooler, and vault storage. Be aware of how products are moving so that you can periodically rearrange their location in the warehouse as needed. A good WMS will show how a system is performing and how products are coming in and going out. 

Within a pharmaceutical manufacturing facility, be sure to segregate products by keeping controlled substances in a locked area. Apply the same logic and flexibility to expensive, dangerous, or hazardous items that need to be kept in a specific place (i.e., safe zone). It is crucial for staff to keep records of date tracking, as most products have expiration dates, which could potentially result in shipping of outdated or near-date product.

One of the most important components of developing a logical warehouse is the staff. The number of warehouse personnel will play a crucial role in operational effectiveness. With a large warehouse staff, consider organizing employees into smaller or specialized groups and assign specific employees to specific areas. Each situation will be unique based on the products a company is moving and the size of the staff. 

Once a warehouse solution has been selected, tested, and implemented, employees should be trained on every component of the system to best maximize the warehouse solution investment and ensure that warehouse inventory is being moved and tracked in the most efficient manner. Whether it is bar-code and radio-frequency (RF) data collection, returns, order management, or other software that is leveraged for warehouse management, personnel need to be trained and become comfortable using this technology.

The key to successfully implementing a warehouse solution and ensuring streamlined operations, automated processes, top efficiency, and reduced costs is to make sure that the most important assets—products and staff—are well prepared and organized in all areas of warehouse operations.

Joe Scioscia is vice president of sales at VAI (

Articles

Troubleshooting

Warehouse layout and personnel training are crucial to successfully implementing a warehouse management solution.

Solving Common Problems in Warehouse Management

Formulating drugs for hot-melt extrusion (HME) was one of the topics at the Pharmaceutical Extrusion Seminar organized by Leistritz near the company’s US headquarters in New Jersey in June. Several of the speakers noted the growing problem of poorly soluble drugs in the drug development pipeline and the need for efficient production methods for improving solubility. While other options, such as spray drying, are available, HME is attractive because it does not require solvents and is a continuous process, which brings advantages of efficiency, flexibility, and process control. 

HME has been used in the pharmaceutical industry since the late 1980s, but because of its growing acceptance and use, the past five years have seen increasing application of fundamental research and understanding of HME to pharmaceutical formulations, notes Charlie Martin, president of Leistritz. This year’s Pharmaceutical Extrusion Seminar (PES) was the 8th annual, and the experience of attendees has significantly increased in the past five years, says Martin. In the first few years of the PES, only 10–20% of attendees had any extrusion experience, but now 80–90% do. In addition, many companies now have research to present. 

One area of research is the use of supercritical carbon dioxide (CO

) in HME for foaming and as a fugitive plasticizer (i.e., a material that acts as a plasticizer or processing aid during the process but does not remain in the final product). Supercritical CO

 reduces the glass transition temperature of polymeric excipients and acts as a molecular lubricant to reduce melt viscosity. Processing temperatures can be reduced by as much as 20 

C, which can be important if the API has low thermal stability, noted Graciela Terife, senior scientist for Pharmaceutical Sciences at Merck, in a presentation. 

Identifying an appropriate polymer to use as an excipient in HME was also discussed at the seminar. Requirements for polymers include high thermal stability, appropriate glass transition temperature and melt viscosity, no toxicity, and, perhaps most challenging, solubility with the target drug, explained Shaukat Ali, technical sales manager at BASF.  He explained that a screening test in which the API and polymer are mixed in a solvent and dried onto a film can be used to evaluate compatibility. Suppliers have done this work with many excipient-API combinations; BASF, for example, has published an 

In the HME process, high temperatures and shear combined with intermolecular interactions (e.g., ionic, hydrogen bonds, and polar forces) between API and polymers breaks up a crystal lattice of poorly soluble actives; the amorphous active is then stabilized within the polymer matrix, explained Firouz Asagarzadeh, director of technical services at Evonik, in a presentation. Miscibility of drug substances in polymers plays a crucial role in formation of solid solutions and stabilization of the amorphous structures. Polymer selection should be based upon structure of the active and polymers. To select appropriate polymers, Evonik has developed a miscibility and process estimation package called MemFis (Melt Extrusion Modeling and Formulation Information System). MemFis calculations do not require use of any active, and using MemFis minimizes screening experiments.

HME also lends itself to direct production of combination products, in which a drug is loaded into a device that can be shaped or molded as part of the extrusion process. HME is being used, for example, to produce fibers loaded with drugs that are injected for local delivery (e.g., ocular drugs), sutures containing drugs for dental applications, and catheters containing drugs or antimicrobials, explained Tony Listro, managing director of Foster Delivery Science.   

Although HME is still a cutting-edge technology, experience and understanding are growing and development continues, as evidenced by the presentations at the seminar. 

Production Trends

Presenters at a pharmaceutical extrusion seminar discussed formulating drugs produced using hot-melt extrusion.

Hot-Melt Extrusion Progress Continues

Honeywell
     Software helps operators better manage manufacturing systems.

Software from Honeywell is designed to improve operational excellence by helping plant workers redefine how they maintain system uptime and reliability while providing safer operations. The Intuition Operations Monitoring software, built on Honeywell’s Intuition platform, is used to help operators keep the process within the best operating zone.  The Control Performance Monitoring software helps engineers to monitor, identify, diagnose, and remedy process-control asset issues across all plant layers.  Honeywell’s latest Alarm Management software helps operators better manage their processes without compromising safe operations. 

Pharma Technology Inc.
  Tablet deduster line offers high-containment with wash-in-place or wash-offline models.

Pharma Technology Inc. (PTI) added high-containment, dust-tight models; wash-in-place (WIP) models; and wash-offline (WOL) models to its PharmFlex line of dedusters. The new models can be used in PTI’s All-In-One (AIO) Tablet Deduster and Tester System. The high-containment, dust-tight model features pinch valves on the tablet inlet, air inlet, and dust extraction ports, as well as PTI’s FlexConnect dust-tight connection, which utilizes FDA-accepted silicone rimming that mates with circular ribs on the inlet and outlet ports. The model includes a pressure-decay test system integrated into the startup routine to ensure full containment and continuous negative-pressure monitoring during operation. The high-containment model is also available as a WIP or WOL model.

Featured products from Pharmaceutical Technology's monthly newsletter, Equipment & Processing Report

July 2013 Editor's Picks: Products from Honeywell and PTI

Packaging and packaging equipment displayed at INTERPHEX (April 23-25, 2013 at the Javits Center in New York, NY) play a significant role in protecting product quality and patient safety. 


To prevent injuries and deaths related to unintentional ingestion or accidental overdose of children’s liquid medicines, the DoseGuard Valved Bottle Adapter System from Comar allows access to the product only when a specially modified oral syringe (also from Comar) is connected to the container. Inserting the syringe until it clicks into place opens a valve in the vented adaptor, thus allowing the proper dose to be withdrawn. When the syringe is removed, the valve closes, which prevents leaks, evaporation, and contamination. Four interlocking ridges on the recessed adaptor prevent it from being pulled out or pushed into the container. Comar molds medical-grade low-density polyethylene (LDPE) and slits the friction-fit component in one operation. Standard diameter is 20 mm. The valve-opening oral syringe may be ordered in 0.5, 1, 3, 5, 10, and 20-mL sizes. 

The new Shaker Single-Dose System from Bormioli Rocco keeps sensitive ingredients separate until it is time to mix a dose. The polyethylene terephthalate (PET) bottle holds the liquid. A medium-density PE plug contains powder ingredients and resides in a high-density PE cap with a polypropylene plunger. For moisture-sensitive ingredients, a desiccant can be incorporated. Turning the cap breaks a tamper-evident band and activates the plunger, which has a cutting edge to release the dry ingredients. Shaking the container mixes the dry and liquid ingredients. After opening, the plunger and plug remain in the cap. A Bormioli Roco partner in Kansas fills the liquid and powder ingredients and assembles the finished package. Containers are available in amber in sizes from 25 to 60 mL. Active ingredient capacities include 0.334, 0.660, and 1.0 cc.

Quality assurance, a perennial concern of pharmaceutical manufacturers, encompasses many technologies, including checkweighing. The SSV checkweigher, a compact unit from Anritsu Industrial Solutions USA, a first-time INTERPHEX exhibitor headquartered in Japan, can be integrated with a metal detector to provide dual functionality. At less than 1 m in length, the combination unit often fits in the space occupied by a metal detector alone. A range of SSV models address different weight ranges and aperture sizes and perform with an accuracy of +/- 0.01 g. The model SSV 6412 BP60 features an aperture with a usable product pass-through height of 180 mm. 

Another compact design, the SL-M-FS checkweigher from Wipotec, separates the weigh cell from the electronics with a 3-m cable. As a result, the unit occupies a footprint smaller than most laptop computers. The checkweigher comes in five models covering weights from 20 to 1000 g and features a washdown option. Operating on electromagnetic force restoration technology, the self-damping units minimize measuring time and maximize resolution. Potential applications include filling and packaging machines, multitrack weighing systems, in-process control, and cleaning in place. 

INTERPHEX returns to the Javits Center in 2014 (March 18-20). Meanwhile, an opportunity to view pharmaceutical packaging innovations will occur at PACK EXPO Las Vegas (September 23-25, 2013, at the Las Vegas, Nevada Convention Center) where a portion of the show floor is dedicated to a Pharmaceutical Pavilion.

Hallie Forcinio is Pharmaceutical Technology's packaging editor, 

Packaging

Containers, components, and quality control equipment help safeguard product quality and patient safety.

Equipment and Processing Report-07-17-2013

Solving Common Problems in Warehouse Management

Hot-Melt Extrusion Progress Continues

July 2013 Editor's Picks: Products from Honeywell and PTI

INTERPHEX Introduces Packaging Safety and Quality Innovations