Iharmaceutical manufacturers face a unique set of operational challenges. As a hybrid of biotech and traditional manufacturing, they must deal with the thorny issues of both industries: strict regulatory compliance, sensitive materials handling, high costs of stopped operations, and wasted products. This industry is amazing and lifesaving but can also be hair-pulling for those in the business trenches.
One of the most impactful investments pharmaceutical companies can make is in secure tracking using smart technologies. Systems like RFID-enabled lockers, temperature-controlled storage units, and key management cabinets can improve pharmaceutical facilities' monitoring and safeguarding of critical assets.
Pharmaceutical companies operate under stringent regulatory frameworks designed to ensure their products' safety, efficacy, and quality.
The Food and Drug Administration (FDA) enforces Current Good Manufacturing Practice (CGMP) regulations in the United States. These regulations outline the minimum requirements for methods, facilities, and controls in the manufacturing, processing, and packaging of pharmaceutical products. They mandate that products be produced consistently and meet quality standards appropriate for their intended use.
Similarly, in Canada, Health Canada provides guidelines interpreting the requirements for Good Manufacturing Practices (GMP) as specified in the Food and Drug Regulations. These guidelines assist manufacturers in understanding and complying with GMP to ensure that drugs meet the appropriate quality standards before they are sold.
Compliance with these regulations requires careful attention to many logistical factors, notably facility design, equipment maintenance, and process control. For instance, the FDA's CGMP regulations require that manufacturing facilities be designed to facilitate cleaning, maintenance, and proper operations, thereby preventing contamination and ensuring product quality. Automating any part of your manual operations facilitates compliance and represents a significant productivity boost.
RFID stands for Radiofrequency Identification and is a highly adaptable, secure tracking solution for pharmaceutical handhelds, kits, tools, and mobile devices. RFID tracking automates tedious manual tasks and enforces rigorous control over asset management. These systems' main benefits are boosting efficiency, ensuring compliance, and maintaining the integrity of sensitive equipment and materials.
While specific setups vary by facility, RFID solutions are composed of a handful of the same core components:
At the heart of the system are secure storage cabinets that house essential equipment when not in use. These cabinets often include charging ports to ensure electronic devices are ready for use and data connections for monitoring fault codes.
Some modern systems use modular cabinets, which allow you to mix and match different storage sizes based on your facility’s needs. Some or all of these modular cabinets can also be temperature-controlled for sensitive biological materials.
RFID tags are the backbone of the tracking system. Pharmaceutical facilities commonly use a mix of passive and active RFID tags. Like those found in ‘tap’ credit cards, passive tags transmit identity data when scanned by an RFID reader, making them ideal for short-range applications.
A built-in battery powers active RFID tags. They offer a wider range and are used for high-value or critical assets. Tags can be embedded directly into devices or attached externally. For example, a two-way radio may have a slot to accommodate a built-in tag. A handheld IR temperature scanner might not, so you need to attach a small, external tag to one.
Most asset management systems employ passive RFID tags, as their smaller size accommodates more types of equipment. Passive RFID readers emit a radio signal that powers up tags they come in contact with, allowing the tag to bounce identification and other data back.
These scans are nearly instantaneous and can ID multiple items at once. Typically, readers are placed at storage cabinets to monitor the removal or return of devices, ensuring real-time updates on asset location and status.
Access terminals on storage cabinets provide a secure interface for staff to check items in or out. Depending on the access control methods already used in your organization and your desired level of security, authentication methods such as swipe cards, PIN codes, or biometric verification are all possible.
Advanced systems may incorporate touch screens that guide users through customized checklists. For instance, staff checking out a tablet can report any device error codes or physical damage.
The system’s management software aggregates data from readers, cabinets, and access terminals into a centralized dashboard. These dashboards are typically accessible on desktops, tablets, and now often smartphones. They provide real-time asset tracking, generate alerts for overdue items, and automatically create detailed reports.
This ensures compliance with regulatory standards and enables supervisors to monitor performance, enhance accountability, and optimize workflows. For example, they can set curfews on signouts for freezer keys when staff conduct inspections of sensitive materials. If a supervisor gets a curfew notification, they know a scheduled inspection didn’t happen and can follow up quickly.
Here are some common challenges encountered by pharmaceutical operational staff and how smart management systems address them:
Maintaining standardized workflows across production lines ensures product quality and avoids contamination. Without automated, secure tracking, verifying whether all necessary equipment, tools, or materials are available and in working condition can be time-consuming at best and lead to delays, regulatory violations, or compromised product safety at worst.
Smart key cabinets and locker systems enforce any workflow involving a key or equipment transaction, handling it in a standardized routine and tracking it for accountability. By integrating checklists and access controls into their systems, they ensure that only properly maintained equipment is used for production, testing, or maintenance activities. Automated alerts for missing or overdue items keep workflows consistent, reducing errors and downtime.
Front-line staff often struggle to locate critical assets, such as keys, biomedical devices, or environmental monitoring tools, when needed most. In some production settings, we’ve heard of staff hiding their preferred mobile devices on the floor so they knew they would have a working one on their next shift. The problem was this deprived other shifts and led to an overall productivity loss.
Smart management systems provide real-time asset tracking, ensuring that teams can instantly locate essential equipment. RFID solutions log every transaction so managers know who has signed out, which items are signed out, and when they are due for return. This cuts time spent hunting for missing equipment, improves asset utilization rates so you can keep equipment pools smaller, and helps keep production on schedule.
Manual tracking processes are obviously prone to human error, which can easily lead to misplaced or lost equipment critical to high-cost work. Replacing these assets or dealing with the resulting production delays adds unnecessary costs. Inefficient tracking also leads to overstocking or underutilization of resources.
Smart lockers and key cabinets automate tracking, significantly reducing errors and shortening the time from missing reports to recovery. With detailed usage logs and real-time alerts for overdue or missing items, these systems improve accountability and help optimize equipment utilization.
Failing to maintain accurate records of who accessed critical tools and when can lead to failed CGMP or GMP audits and therefore fines. Not to mention, if safety standards aren’t met they could also lead to production halts and workplace injuries.
Smart tracking systems generate detailed, automated records of equipment use, providing a complete audit trail that satisfies regulatory requirements. Advanced access controls, such as biometric authentication, securely ensure that only authorized personnel can access critical tools or devices.
Without automated tracking, identifying and addressing maintenance issues becomes reactive rather than proactive. Just one piece of faulty equipment can disrupt production, compromise an entire run, and result in costly rework.
Smart management systems monitor equipment conditions and automate maintenance scheduling. Alerts for overdue repairs or calibration ensure equipment is always production-ready. With these systems, managers can prevent disruptions and maintain high standards for quality and compliance.
Temperature-sensitive drugs require precise monitoring to ensure they remain within safe temperature ranges. Misplaced, uncharged, or improperly calibrated monitoring devices increase the risk of temperature deviations.
Smart lockers provide secure, organized storage for monitoring devices like temperature probes, ensuring they are always accessible, charged, and ready for use. Management systems log each device’s location and condition using RFID solutions.
Integrating smart asset management systems with your other business systems can generate significant value and improve efficiency across departments.
Linking your smart lockers and key management systems to your access control network provides tighter security and easier administration. For example, only authorized employees can retrieve specific keys or equipment, and access logs are automatically synchronized across systems. They use the same credentials they use for building access.
For businesses with fleet operations, integrating key management systems into fleet work ensures smoother vehicle tracking and usage. Smart key cabinets can house and track fleet keys, ensuring that only authorized personnel can access vehicles. Real-time updates enable managers to monitor key checkouts, vehicle assignments, and returns. Employees can reserve keys for specialized trucks, forklifts, or other vehicles.
Smart management technology can also integrate with IT support systems to streamline device management. For instance, a tech support locker can securely store broken laptops, tablets, or other devices for repair. Employees can deposit damaged items and retrieve replacement devices from the same system, and the IT team will be notified automatically.
Whether it’s temperature-sensitive pharmaceuticals waiting for distribution, shared biomedical devices, or high-value materials requiring secure handoff between shifts, smart lockers ensure proper tracking and handling. Integration with logistics and inventory systems provides visibility across the supply chain, reducing loss or mismanagement.