Dear Vaisala,

We are hoping to save time in creating a Standard Operating Procedure for our viewLinc monitoring system. Does Vaisala offer any reference materials for viewLinc SOP?

We understand that an SOP is basically created and managed by each customer, but a sample would help as a starting place…
Thanks for your help!

Paul Daniel writes:
Thank you for reaching out to us!

The regulatory requirement is that a GxP-regulated application have a written procedure describing the monitoring process and written storage specifications for products.  It is a simple requirement that can be interpreted into many different methods of documentation, including SOPs.

When using a computerized monitoring system (such as viewLinc) to monitor the temperature of a physical space (like a refrigerator or warehouse), the procedures created will be quite similar because they are based, in part, on the software.

The variations occur in how a particular company chooses to create storage specifications and written procedures.  From company to company, there are different approaches to documentation, policies, policy implementation, specifications, and procedures.

It is my hope that companies that like detailed SOPs (see variation #5 below) can reference the Tours that are in viewLinc. viewLinc Tours give onscreen instructions for common tasks in viewLinc to ensure users can complete tasks the first time they use the software. Tours help users complete tasks the same way each time they use the software – especially useful if you only perform certain tasks occasionally. The tours can definitely make SOPs much easier to write, follow, and maintain.

Here are some variations in how SOPs can be created for viewLinc:
1. Storage specifications may simply be the conditions on the label and not a specific document.
2. Storage specifications may be grouped into categories, such as refrigerated (2 to 8°C), cool (8 to 15°C), room temperature (15 to 25°C), etc.
3. Specific chambers or rooms may be assigned such a temperature category.
4. There may be several generic SOPs that apply to all computer systems, including password management, audit trail review, employee on-boarding, system backup.
5. There may be a detailed SOP for how to use the monitoring system. Like so: do this, click here, write this in that field, click save, etc.
6. There may also be a detailed SOP based on specific monitoring goals (keep medicine A between 2-8°C and file a deviation if the temperature is out of specification for over 30 minutes). This may say very little about how to use the actual software, and rely on the user manual instead for instructions.

The range of possibilities is so wide that it has not proven to be useful for Vaisala to create a template SOP for our customers.  Most customers have to follow their own internal policies on creating written procedures, so many do not often have the freedom to follow our recommendations or a template.

Here are my recommendations for documentation to create in-house in support of viewLinc software:

• A specification document
o This lists the allowable temperature range for each area or unit type, including allowable excursions (maximum temperatures and times) and expected responses to these excursions.  This should also list the responsible persons, by title rather than by name to avoid revision every time there is a personal change.

• A configuration specification document
o This describes the settings for viewLinc, including establishing a limited number of security profiles (called: “Groups” in the software) and a limited number of alarm threshold and notification templates, as well as a drawing, and a table of the physical location of each device, and to what “Location” in the software it links to.  This will help create and maintain order and naming conventions within the system.

• A monitoring SOP
o This describes the high-level actions taken within the monitoring system with very simple sentences. For example: Acknowledge the Alarm, Create a User, etc.  Such a document is easier to maintain and follow if it is simple. When a more detailed process is needed, it can reference viewLinc’s User Manual or the Tours.

Related Webinar

In our webinar "Audit-proof your Monitoring System" I have a chapter outlining SOPs. You can access the slides (PDF) here and watch the recording.

Further reading on GxP compliance for continuous monitoring systems.

SOP Examples:

Just for reference, here are a few examples. But, it’s the responsibility of every facility to create their documentation around the system to ensure their compliance and operational goals are met.

Alarm Acknowledgement

This section of the SOP specifically details the types and steps to respond and acknowledge CMS alarms. All users can receive alarms, but only specific users with the proper access level can acknowledge alarms. This facility’s alarm threshold set points are set per Table 1 of this SOP. Set point changes must be approved per the Process Change Control SOP.

Step Action
1. Facility and/or calibration departments are responsible for receiving/acknowledging alarms via cell phone (text) and/or emails.

2. In viewLinc select the Alarms / Active Alarms Tab. Then select the active alarm to acknowledge.  Reference Environmental Monitoring Location Map, if needed, to verify alarm location.

3. Follow Figure 1. Alarm Investigation Flow Chart.  Based on flow chart continue with acknowledging alarm. Facilities and/or calibration technicians must notify Facilities Engineering and Supervisor once an out-of-limit (OOL) condition is confirmed.

4. For communication alarms, a system check is required once connectivity to the server has been re-established. A channel history report shall be reviewed by Facilities Engineering to confirm no data loss and to confirm all sensor locations are reporting temperature, humidity, and differential pressure readings.

5. For configuration alarms, a system check is required to ensure connectivity to the server. A channel history report shall be reviewed by Facilities Engineering to confirm no data loss and to confirm all sensor locations are reporting temperature, humidity, and DP readings. System configuration shall be reviewed against CMS Configuration Spreadsheet attachment of site validation report.

Email Settings Management

a) Email settings rarely require changes after the system is initially configured.  However, if network changes are made that affect emails, it may be necessary to update the email settings.
b) The Email Settings window is access through Options > System Configuration > Email Settings.
c) The Email Settings use standard mail protocol settings, such as SMTP, and POP3 (if required). 
d) Enter any changes that are necessary.  After changes are made, the settings may be immediately tested by selecting the “Test Email” option from the Email Settings: Options drop down menu. 
e) Save all changes before exiting the Email Settings window.
f) NOTE: The appropriate facility change control process may be applicable to any changes to email settings.

Finally, here is a blog from The FDA Group that gives a good outline on writing SOPs.

Vaisala Hardware – Testing Beyond Promise

At Vaisala, we put our products through a series of environmental and mechanical tests to learn the points of failure or weakness. We test beyond what we promise, in temperature, vibration, drop heights, and more to ensure the hardware is robust, reliable and accurate. In this longer version of the video, Senior Engineer Fiki Jusuf describes the testing process.

Open video

Additive manufacturing is rapidly gaining pace as a commercially viable industrial manufacturing technology following the global trends of on-demand production, customization, and the need for savings in time, money, and materials. Whether manufacturing plastic or metal parts, some raw materials such as powders, resin, or filaments are hygroscopic, meaning they absorb moisture from the surrounding ambient air. High moisture levels within the raw material can change its chemical properties and may negatively affect final product quality.

Metal Additive Manufacturing
Additive manufacturing of metal parts is becoming increasingly popular because it can offer new solutions not available with traditional manufacturing techniques. New shapes and techniques that were previously very expensive or even impossible to design using traditional casting and machining methods are now at our fingertips. Products manufactured with a 3D printer can be significantly lighter and just as strong – or even stronger – than their equivalents produced using conventional methods. These features are especially valued in aviation-related applications where tolerances are extremely tight, with each saved gram of metal translating to big savings in the product life-cycle analysis.

Another significant advantage in metal 3D printing is the improved printing speed and production rate. This technology is already challenging traditional manufacturing methods in mass production markets. The ability to reproduce high-quality products is essential to mass production and critical end-use applications such as aerospace, automotive, or medical components. 

Moisture plays an important role in many stages of the manufacturing chain so, to ensure consistent quality, it is essential to make sure conditions in facilities throughout the production chain are stable. Manufacturing and storage facilities for equipment and materials should be temperature and humidity controlled to ensure a high-quality product. 

High-quality additive manufacturing requires high-quality raw material. The powder materials such as aluminum or titanium alloys used in the selective laser melting (SLM) process are sensitive to ambient humidity. If the powder absorbs too much water from the surrounding air, its chemical characteristics can change dramatically, leading to loss of print quality. All storage conditions, whether inside or outside of the printer, should be carefully monitored to ensure that the raw material meets the manufacturer’s specifications.

With metals, regardless of the 3D printing method used, there is a sintering or melting process that fuses metallic powder to the solid metal part. The sintering must take place in an inert environment with low levels of oxygen and moisture. This can be a harsh environment for any measurement device, but the conditions can also be monitored indirectly through dew point measurement of the inlet and outlet gasses.

Plastic Additive Manufacturing
Moisture is a well-known enemy of plastics. As many polymers are hygroscopic, they will absorb moisture from the surrounding air. As a manufacturer, you do not want your raw material to change its properties – the target is to keep it as consistent as possible. This requires high-quality moisture control throughout the production chain, from filament manufacturing to the 3D printing process itself.

Fused filament fabrication (FFF), also known as fused deposition modeling (FDM), uses a filament of thermoplastic material extruded to the printing platform layer by layer. These filaments are made from a variety of polymers such as ABS (acrylonitrile, butadiene, styrene), PLA (polylactic acid), or PA (polyamide, more commonly known as nylon). All of these polymers have the ability to absorb water, with the amount dependent on the polymer type and the relative humidity of the ambient air. The effects caused by the moisture also depend on the material. 

Some materials, like ABS, can withstand relatively high concentrations of moisture without any impact on their material strength, but problems may still emerge during extrusion. When ABS is heated above 200°C the absorbed moisture will evaporate and turn into steam. This causes issues in the print quality since the steam will affect the material flow. Some materials, such as PA (nylon) also suffer from hydrolysis. This means that water molecules damage the polymer chains during extrusion and the material loses its tensile strength.

Conclusion
Whether you are manufacturing your parts out of metal or plastic, you will need to keep a tight control over the conditions in all parts of your facility. To avoid any production quality issues caused by moisture, you need accurate measurements. 
 

PDF version

 

“You use biological indicators and other equipment annually to re-qualify an isolator. Between re-qualifications, you have to assume everything is stable. But if you have a sensor monitoring the isolator for each cycle, you can troubleshoot between re-qualifications. I believe that inline monitoring is useful in isolators regardless of the application. Unfortunately, this is not always done.” 

New Webinars

Join us for two new webinars for life science applications:

From Monitoring to Controlling with vaporized Hydrogen Peroxide Sensors:  Why, How & a Case Study

We are joined by Cleamix, a provider of Vaporized Hydrogen Peroxide generators, to provide a case study on bio-decontamination. The focus is hospital decontamination, but the process and principles are applicable to any vaporized hydrogen peroxide applications.

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The Benefits of Refractive Index (RI) in Development and Production of Active Pharmaceutical Ingredients (APIs)

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The requirements for testing different products, materials, and components can vary a lot depending on their intended application and other performance criteria. Demanding end uses such as automotive and mobile devices require components that are comprehensively tested to prove their performance and safety. These tests are usually done in the climate chambers. The climate chamber being used for testing must be capable of accurately replicating the required extreme climate conditions. Repeatability is another important factor in terms of ensuring that all test batches are subject to exactly the same conditions.

Precise control is crucial when moving from a standard test setup to an extreme one, and in order to have this level of control accurate measurement is needed even in condensing conditions. Traditional humidity measurement equipment cannot cope with the conditions inside a climate chamber because when the sensor gets wet, it needs time to dry out in order to start measuring accurately again. However, using a measurement module with warmed-probe technology ensures precise control over conditions inside the chamber even in the most demanding tests, such as dew cycle tests and humidity-based HALT (Highly Accelerated Life Testing).

One other factor which may also cause challenges is that the specimen are tested in elevated temperature. Plastic parts in the specimen may vaporize volatile organic compounds that can end up in the capacitive humidity sensor. This can cause drift in the humidity measurement. This issue can be avoided by heating up the humidity sensor rapidly up to 180 °C. This temperature treatment, called as chemical purge will vaporize the organic compounds away from the sensor and the drift effect is cancelled.

Warmed-probe and chemical purge technologies are available with the Vaisala HUMICAP® Humidity and Temperature Module HMM170. This module can measure humidity in conditions from 0 to 100 %RH and has a heated probe that can tolerate pressures from vacuum up to 10 bar. The circuit board footprint is designed to enable easy integration with your climate chamber’s existing configuration: the HMM170 includes three configurable analog outputs and one digital output (RS-485/MODBUS RTU). The chemical purge function can be initiated via contactor or Modbus. This is an easy way to ensure that the sensor is contaminant free before the next test patch. Configuration and calibration is done via a USB cable using the Vaisala Insight PC software.

For more information, visit www.vaisala.com/HMM170.