RFID Tags in Critical GMP Areas including Clean rooms

gmp room cleaning

Organizations have to apply well defined GMP practices in Clean rooms and labs in order to maintain particulate and pathogen free environments. There are formal requirements and guidelines for food, drug, medical device and cosmetics manufacturing such that sanitized conditions are maintained. There are several cleaning standards including the ISO14644 and the Federal Standard 209E standards. Such standards can bring up some unique challenges when it comes to tracking assets inside these areas. Since they are operated under strict guidelines, they are subject to several cleaning methodologies. Some of the common SOPs (standard operating procedures) include chemical wipe downs, autoclaving etc.

gmp room cleaning

1. RFID tags can withstand Chemical wipe downs:

This means the RFID tagged assets in the clean rooms are also going to be subjected to the cleaning SOPs. Wipe downs can be done with oxidizing agents like hydrogen peroxide or non-oxidizing agents like alcohols. RFID tags have to be rugged enough to withstand these wipe downs. In areas such as Cleanrooms where such SOPS are enforced, particular attention has to be applied to RFID tag selection. Not only should the tag have a good read range, as is the default requirement, but it should be made of material that will remain unaffected when exposed to such chemical wipe downs. It’s also important to note that equipment in clean rooms tend to last many years, which implies that the RFID tags chosen, should also be rugged enough to withstand chemical wipe downs for many years.

2. RFID tags that can withstand autoclave process:

Further, several types of equipment will need to be cleaned in autoclaves. Autoclaves use a combination of steam and pressure over a significant period of time. They need to run at very high temperatures and pressures so the pathogens, microorganisms and spores can be destroyed. Metal, glass and various plastic materials may be autoclaved. Not only should appropriate RFID tags suited for the specific type of material be chosen, but it also must be ensured that they can repeatedly tolerate autoclave environments for a period of years.

3. RFID tag with special mounting options:

RFID Tag mounting methodologies should also be carefully considered. Often, commonly available adhesives will not withstand chemical or autoclaving environments for a long and extended period of time. Special adhesives or alternate mounting techniques need to be employed. Hanging, riveting or screwing down RFID tags in autoclave environments is recommended.

AssetPulse, with its decades long experience in such ruggedized environments, has deployed thousands of RFID tags in multiple clean rooms. Not only is selection of RFID tag important, but also the location of the tags should be optimally specified. AssetPulse personnel study the SOPs employed in the areas to see what the best location for the tag is, so read range can be maximized while at the same time, protecting the tag from unnecessary mechanical impact, shock and vibration.

Further, in case a fixed RFID reader infrastructure is needed in clean rooms, the readers, antenna, cables etc. need to be situated in appropriate configurations such that they deliver the required performance, but at the same time, are able to tolerate the environment. This can be challenging, but is well within the AssetPulse wheelhouse.

 

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Equipment Tracking and Calibration Management in Cleanrooms Automated with AssetPulse RFID Asset Tracking Solution

RFID Cleanroom

Do you know what equipment has to go to Metrology for calibration? Do you know when it was removed from the cleanroom and whether it has gone to Metrology? Was it brought back to the Cleanroom and if so, when?

Equipment Management in Cleanroom

Cleanroom management in a biotech or high-tech company poses several challenges, many of which, if not addressed effectively, can severely impact the company’s bottom line. One of the many challenges is facilitating the strict adherence of the calibration schedule for all test and measurement equipment. This means, not only ensuring that the equipment is removed from the Cleanroom and sent to Metrology, but also that the equipment is returned to the right location in the Cleanroom from Metrology. Cleanroom management has very little visibility into this process. Several times, equipment may leave the Cleanroom, but is not delivered to Metrology in a timely fashion. Often calibration is completed, but the Cleanroom is not aware of it and the equipment is sitting on some shelf waiting to be returned to the Cleanroom.

RFID Cleanroom

AssetPulse Solution for Lab Equipment Management in Cleanroom

A global medical device company faced similar challenges for several years. These problems were of course exacerbated by its explosive growth, thus exposing it to more severe consequences. Over the years, it tried to address them with process modifications and applying various technologies.  With the AssetPulse lab equipment tracking solution – a combination of well-selected RFID tags, appropriate reader configurations and well-tuned asset tracking system, they were able to finally address the problems effectively. Not only were they able to get complete visibility of how the RFID tagged test equipment moved between the Cleanroom and Metrology, but they were proactively alerted when there was a break in the process – when equipment wasn’t delivered to Metrology in a timely manner or if calibrated equipment wasn’t returned to the Cleanroom when ready.  

Automated Asset Tracking software

  • Equipment movement from and to Cleanroom were monitored in real time by Fixed RFID readers
  • Metrology doors/portals were instrumented with fixed RFID readers.
  • Additionally, shelves that held calibrated equipment, waiting to be picked by Metrology were RFID instrumented.

The AssetGather automated RFID asset tracking solution alerted Equipment Managers that calibration was completed and that they could pick up their equipment at Metrology. Automatic tracking alleviated the shortcomings of the manual process involved in keeping track of equipment moving between Cleanrooms and Metrology.

In order to realize the full potential of AssetPulse RFID asset tracking solution it is very critical to choose optimal RFID tags. Not only do they have to be mounted on very small pieces of equipment including 6” rulers, but they also have to withstand the sterile environment of the Cleanroom. This means they have to withstand chemical wipe-downs and sometimes more rigorous cleansing.  AssetPulse offers tried and tested RFID tags of different form factors and properties like the ability to withstand extreme environmental conditions and to sustain exposure to chemicals.

When it comes to High-Tech Cleanrooms, equipment might need to be sent to third-party calibration houses. One or more locations can be designated for holding equipment that is being sent out for calibration. These locations are monitored automatically and the Cleanroom Equipment managers can be notified when equipment is removed from these locations to be sent out. When they are returned from the Calibration company, the managers are notified, so they can go pick them up from those locations and place them back in the Cleanroom.

 

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RFID Asset Tracking for Lab Relocation

Laboratory Relocation Services

Is your company growing? Or are you downsizing? Either way, there is likelihood that your labs are being relocated. Laboratory relocations present a unique set of challenges and are huge headaches for lab managers. First, lab managers need to have an accurate inventory of their current equipment. Not only what they have, but also where everything is. Inventory tracking and equipment location tracking is simplified by AssetPulse Lab equipment tracking solutions. Now that the lab managers have clear visibility of where each of the equipment is, they need to decide what equipment goes where, in the new location. Equipment has to be packaged and marked with care before they are moved.

Laboratory Relocation Services

Laboratory Relocation Services

Unfortunately, mistakes are bound to happen. Packages are mislabeled. Equipment is not delivered to the right lab. Well meaning personnel, will move packages out for legitimate reasons, without informing anyone. The lab manager is tearing his or her hair searching for misplaced equipment. These are not uncommon scenarios.

RFID Asset Tracking Solution in Relocation of Labs

One of our long term customers who has implemented our RFID based asset tracking solutions just went through a move. The complexity of lab instruments, regulatory requirements and the need to address lab workloads during a move demands exacting processes. With our RFID enabled lab equipment tracking system, they had an accurate inventory of all their equipment and more importantly, where each of the equipment was located. They were able to plan the move efficiently – which equipment goes to which destination. Equipment was packaged. Some labeling mistakes were made. Equipment did get misplaced.

However, because all the equipment had been RFID tagged, and the major exit and entrance doors had been instrumented with RFID readers, our RFID asset tracking system accurately tracked what equipment was moved when and through which doors when they entered in the destination buildings. Even if a piece of equipment was incorrectly delivered to a lab, our asset tracking solution alerted the lab manager of the error. So, they knew where exactly to go search for the equipment with a handheld RFID scanner. Since the RFID tags are able to be read through the packaging, they didn’t have to undergo the laborious processes of opening the packaging and trying to read the asset number of the equipment inside.

With our RFID system, the entire relocation process, from planning through execution to completion, was a much smoother, much quicker and more painless process for not only the lab management personnel, but also for the users of the labs. This had direct impact on the business, because it not only made efficient use of personnel’s time, but also got the labs back on its feet quicker, so the business suffered minimal disruption.

 

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Pipette Management and Calibration simplified with RFID

RFID Based Pipette Tracking Software for Laboratory

Are you in charge of a bio lab where you need to manage calibration and servicing of pipettes?

We empathize with you. We know Pipettes are crucial to experiments conducted within labs. However, they also tend to move around a lot – yes, a lot! Not only is trying to make sure pipettes are in the right lab a challenge, but it is harder and more imperative to find them when they are due for calibration.

RFID Based Pipette Tracking Software for Laboratory

Using RFID asset tracking for pipette management is a great solution to address these issues. AssetPulse has worked with world leading pharmaceutical companies to track their pipettes. Pipettes require special type of RFID tags due to their unique form-factor. AssetPulse has an array of RFID tags that can be used to track pipettes. Having affixed RFID tags on these pipettes, inventory audits using RFID scanners have become a lot quicker and it also has become easier to locate the pipettes when they come up for calibration.

RFID Asset Tracking – Eases Calibration Process

An RFID instrumented bin can be placed at optimal locations in or around the labs. AssetGather’s Alerting System notifies users/lab managers of upcoming pipette calibrations. With the aid of a mobile RFID scanner, these pipettes are located and placed in one of the bins. Notifications are automatically sent to the pipette manufacturer or the third party calibration company, who can then schedule a pickup or send over personnel to perform the calibration onsite. With AssetPulse’s RFID enabled Pipette Asset Management System, not only do users and lab managers know what types of pipettes are up for calibration, but also how many of each AND their individual serial numbers.

RFID tagged pipettes can also help the Calibration company to efficiently track them when they enter the facility.  Their personnel are notified as soon as the pipettes enter their facility, so appropriate resources can be allocated to service them. On completion, the customer can be notified that calibration was completed and that they are ready to be shipped back to the labs.  The pipettes are deposited in the lab bins upon arrival from the Calibration company and the lab manager is notified that they are now ready for use.

RFID can provide visibility into the ‘calibration supply chain’ process end-to-end!

 

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RFID Based Asset Tracking aids in GLP/GMP Regulated Lab Management

lab equipment tracking software

Being responsible for the equipment in a GLP/GMP regulated lab is no easy task. Several compliance requirements have to be adhered to. AssetPulse’s RFID asset tracking solutions have greatly helped streamline the equipment management of such labs.

lab equipment tracking software

lab equipment tracking software

AssetPulse Real-time Asset Tracking Software

Our real-time asset tracking solutions provide an accurate inventory of all equipment across geographic locations. It can detect addition or removal of components in qualified systems like HPLCs. The Lab Manager can be alerted of such movements, thereby triggering a re-qualification process automatically. Failure to re-qualify can have serious technical and financial repercussions.

Before the use of RFID, the equipment databases were woefully out of sync with reality. This resulted in Finance and QA departments to initiate audits often, in order to update their databases. Small teams of scientists/researchers would need to be assembled, to scour the labs looking for equipment, severely impacting their overall productivity.

AssetPulse Asset Tracking Software Maintains Centralized Database of Asset Information

Maintaining accurate inventory of all the equipment and keeping their details up to date can be a full time job. Details include location, manufacturer, model, serial number, receive date, deployment date and all maintenance related information including calibration/maintenance schedules, non-routine repairs, performance verification and revalidation dates. The AssetPulse database allows all such detailed information to be maintained in one central database, accessible to all concerned players including R&D, Quality and Finance personnel.

Further, the database allows all relevant documents to be stored together with the equipment details. IQ/OQ/PQ documents, standard operating procedures, warranty certificates, calibration certificates can be made easily accessible through the database. This allows audits to go a lot quicker, instead of having to sift through a myriad of documents in order to locate the appropriate pieces of paper.

Thus, the use of RFID can effectively bridge any visibility gaps with respect to Asset Management in Analytical labs, hospitals and in pharmaceutical manufacturing supply chains.

 

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