The University of Chicago Hospitals is on the U.S. News and World Reports Honor Roll of America's Best Hospitals. No small achievement, this designation reflects the attention to detail that is apparent in the University Medical Center’s laboratories.
The Cellular and Tissue-Based Processing cGMP Facility follows the FDA’s guidelines for current Good Manufacturing Practices. The facility is a Class 10,000 cleanroom that is used to develop new cellular therapies for investigational clinical trials.
To monitor the cleanroom environment, samples for bacteria and fungi are taken from more than 120 areas throughout the facility. Previously, each Petri dish was hand-labeled with the date, location in the facility, and type of sample. Labeling was a laborious task and the hand-written marker ink was likely to smear. Labels provided by Brady Corporation (Milwaukee, WI) have streamlined this process and made it less error prone. When the Petri dishes are sent to the Microbiology Laboratory for observation, they are always readable and easier for the technician to read and process.
The labeling equipment used is the BradyPrinter™ model BP-1344. With this printer, compact enough to fit on a laboratory bench, labels can be produced for vials, slides, Petri dishes, cryobags, or any type of specialty items used in a laboratory environment. In addition to saving time in handwriting labels, the legibility of the printed labels is consistent and adds a professional look to all labeled items.
The laboratory technicians found the printer to be easy to use and felt that the learning curve was very short. Any questions or additional supplies could be handled with a simple telephone call. The equipment supplier was very amenable to working with the laboratory staff to make sure they were comfortable in all aspects of use.
Plans are in place to use the labeling system with a sophisticated software program that is currently in development. The system will bar code and track all material and reagents used in the production campaign for each clinical trial. Before new material enters the cleanroom, it will be labeled with a bar code. Processing will be improved significantly by simplifying the tracking of inventory levels and expiration dates, producing batch records for each product campaign, and providing the location and history of the material.
The labels are specially designed to provide all the attributes required in a laboratory environment, and are still legible and intact after immersion in liquid nitrogen at –196 °C. The printer is compatible with the sophisticated bar-coding equipment that will be utilized in the laboratory.
In the Hematology/Oncology Research Laboratory, technicians perform hemapoetic cell, stem cell, Tcell, and leukemia research. The BradyPrinter model 1344 with Brady CodeSoft™ software is used here as well. The custom labels are designed to fit 1.8–2.0 mL vials. Prior to using the equipment, the small vials were very difficult to label legibly. It previously took researchers 1 hr to label 100 vials; it now takes 10 min (80% faster).
The benefits of utilizing the labeling system in the Hematology/Oncology Research Laboratory include increased efficiency, maintenance of sample integrity, and a professional appearance to the vials. The fact that the labels still adhere after the vials are exposed to liquid nitrogen is also an important factor. The printer is valuable because the vials are labeled in a professional manner. Labels that are inconsistent or illegible would be a poor reflection on the laboratory. Plans are under way to relabel samples currently in storage so that sample integrity can be maintained for a long time to come. Label materials are available that adhere to already frozen/frosted vials (also manufactured by Brady) so that the laboratory can avoid thawing the samples to affix the label.
Within the University Medical Center complex is the Cell Engineering Laboratory, which performs therapeutic clinical work with patients at the Medical Center. Stem cells are extracted from patients and stored for several weeks. Following this, between two and ten million cells are infused back into the patient. Since these cells are stored short term for patients and longer term for research, quality control is of the essence. It was vital that an identification system be in place that left no room for error. Labels that could be run through a laser printer and could withstand immersion in liquid nitrogen were a necessity.
The technicians experimented with different labels but found that they were more suitable for an office environment than a laboratory. Tolerance of the labels to liquid nitrogen was a key element, and the laboratory investigated different solutions before finding one that was the most beneficial. The data are stored in an Excel™ (Microsoft, Redmond, WA) file. It was important that the data not have to be reentered after labeling. With the BradyPrinter model MVP300 printer, the data can be imported from the Excel file into CodeSoft software, which processes the information and arranges the data correctly for output.
Labels are needed for vials, vial tops, and cryobags that are then frozen. An important criterion was that the technician would not have to change out materials and print out a separate label for each related piece. This application need was addressed with a label that prints out in a block, but contains individual peel-off labels for each related piece in the correct size and shape and with the needed information. All of the labels can be printed out at one time, making labeling much more efficient, saving time, and increasing accuracy.
While the researchers were impressed with the custom solution, before purchase they wanted to confirm that the labels would be operational and withstand the extremes of the laboratory environment. This was tested by soaking a sample with a label in liquid nitrogen for two months. That the sample was removed and the label was intact substantiated their decision. Its ability to bar code was another key attribute of the printer.
The labeling equipment described here addresses the specific needs of the laboratory environment. The University Medical Center’s laboratories have found that use of the BradyPrinter model 1344 and MVP300, the companion CodeSoft software, and the related laboratory label materials has significantly streamlined the labeling process and made it less prone to error.
Ms. Ostrega is Director, Cellular and Tissue-Based Processing cGMP Facility; Ms. Damacela is Manager, Cell Engineering Laboratory, and Ms. Ulaszek is Laboratory Manager, Hematology/Oncology Research Laboratory; Kovler Laboratory 039, 910 E. 58th St., Chicago, IL 60637, U.S.A.; tel.: 773-702-2111; fax: 773-702-7195 e-mail: email@example.com.