Mapping Services from Rotronic

Ensuring product quality while in transit or storage is an important part of the GxP guidelines. To comply with the legal regulations all storage and transport facilities must be thermally mapped to ensure products are not being affected by extreme temperatures. Rotronic specialises in these services and offers efficient and tailored solutions.

What are the typical temperature mapping Applications?Wherever temperature-sensitive products are produced, stored or transported, mapping is indispensable to show that product quality requirements and standards are being met. mapping-process

What do we offer?
Rotronic will discuss with you the details of your mapping project, including timescales, budgets, regulatory requirements to ensure we deliver the optimal schedule. We offer a transparent service structure ensuring you get only what you need. This segmented service has been very well received by our customers. We can even present and detail all GxP compliant data directly to your auditors taking all the stress out of your audits.

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How will you benefit?
• Modular service structure
– Transport qualifications / validation
– Temperature mapping study
– Stress tests – and findings
– GDP training for dealing with drugs
– Servicing and maintenance of the entire system
• Competent supervision by experienced and qualified engineers
• Best accuracy test equipment and competence as renowned logger manufacturer

What do you get?
• Accurate climate data of measured environments (Warehouses, Room, Lorries, etc …)
• FDA and GxP-compliant mapping reports (Basis for audits)
• Detailed data analysis (Provides information on critical areas)
• Ongoing monitoring and alarming on request

What other GxP-Services does Rotronic offer?
• Validation
• Calibration
• Engineering
• Personnel training

What parameters to be monitored?
• Temperature
• Relative Humidity
• CO2
• Differential pressure and Pressure

mapping-options
Rotronic offers device ranges for all applications

Wish to discuss a mapping project? Please contact us today!
Dr Jeremy Wingate

The Hygroclip2 Advanced Revolution + Evolution + Innovation

This month Rotronic launch the Hygroclip2 Advanced range (HC2A). This is important especially for all our existing customers as the HC2A range will replace the existing Hygroclip2 (HC2) range.

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Firstly, why change?

The HygroClip digital probe was launched in 1999 a revolutionary product that set the standard for accuracy, stability and changed the market by offering digital interchangeability and the inclusion of calibration and adjustment data on the probe. Ten years later our entire range was updated to the HygroClip2 a modern digital probe with a far greater digital capability. The HC2 provided more advanced calibration and adjustment as well as data logging and sensor diagnostics. Manufacturing processes were also improved. Since then it has nearly been 10 years again and so it’s time to further develop the HygroClip.

This year we have seen the launch of several new HygroClip solutions, Our Low Dew Point range (HC2-LDP) utilises our next generation AirChip4000, our new ATEX range (HC2-EX) gives a well needed update to our intrinsically safe devices and now the HC2A brings a number of subtle evolution’s to our flagship product the HC2-S.

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Nearly 20 years of development brings us to the HC2A

What’s new in the HC2A;

  • Much more robust HT-1 sensor which measures up to 93°C dew point
    • This sensor has been used in industrial probes for the past 12 months with proven performance
    • Allows measurements up to 95%rh at 95 °C
    • Also can withstand temperatures up to 200°C for longer durations
      • 190°C long term
      • 100 hrs at 200°C without increased drift
  • New improved housing with fully potted electronics
    • Further increasing the resilience of the HygroClip in the most demanding applications
  • Standardised and fully interchangeable filter for all  upcoming HC2A probes
    • Simplified filter design and options, also ensures sensors are mechanically protected even when changing Polyethylene and Teflon (PTFE) filters.
    • Industrial wire mesh and sintered steel filters are now single modules preventing leaks
  • Completely backward compatible to HC2
    • No new hardware or OEM device changes required!
  • Improved power management
    • Improved power supply regulation

So what does this mean to customers already using our HC2 probes.

Firstly what produces are affected. The changes to date impact our standard HC2-S(3) and HC2-SM probes as well as their Hydrogen Peroxide resistant counterparts the HC2-S(3)-HH and HC2-SM(3)-HH. Wider industrial ranges will be updated in due course.

Compatibility

  • HC2A and HC2 range devices use the same electronics so are completely compatible in terms of
    • Power supply
    • Power consumption
    • Digital and analogue outputs.

Changes

  • Filters;
    • Only affects HC2-S and HC2-S3 probes
    • The HC2A range incorporates a similar filter and filter carrier system as used on existing industrial probes.
    • The filter thread is different as such a new range of filters and carriers are available for the HC2A range
    • All HC2A probes (standard and industrial) will use the same range of filters and carriers
    • Wire mesh and sinter-steel filters are physically mounted to the carrier to prevent minor gaps and leakage.

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  • Dimensions
    • The HC2A-S poly-carbonate probes are 23mm longer
    • The HC2A-SM stainless steel probes are 2mm shorter

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  • Construction
    • Automated sensor production
    • Greater space between sensor pins with domed construction to prevent condensation formation around connections
  • Sensing element
    • The HC2A range utilises our HT1 sensor. A subtle change to the IN1 sensor previously used. The new sensor design improves its physical properties and can measure up to 93°C dew point.

hc2s-accuracy

Price

  • Probe pricing remains the same as existing HC2 ranges.
  • Filters and carriers are also priced the same as current equivalents.

In Summary

Experience from over the past 50 years has been combined along with specific development and testing during the last three years to bring the further advancements to our flagship probe range. This gives us the confidence that the HC2A probes are already a mature humidity and temperature solution which further advances our customers ability to measure humidity with the excellent quality and long term stability expected of Rotronic products.

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A desire to ensure better measurements along with the growing demands and expectations from our customers drives us continually improve and develop our products and services. Watch this space as this year will see further announcements from Rotronic as we look to the future after over 50 years helping our customers make quality measurements

Dr Jeremy Wingate
Rotronic UK

Win a Smartwatch with Rotronic Measurement News 2016

As always our annual Measurement News includes a competition! this year you have the chance to win one of three Swatch Smartwatches – and it is closing very soon!

Swatch-Touch-Zero-One-Volleyball-Smartwatch-1

To get your chance to win answer the simple questions at the end of this years Measurement News which you can view or download below!

Competition entries must be in by 31st August so get cracking!!

Dr Jeremy Wingate
Rotronic UK

Measuring in clean rooms – Hands on with the Rotronic CRP5

For many years Rotronic products have been widely used in the monitoring and control of clean rooms, however more often than not our products are found out of sight quietly performing their measurement tasks away from areas with strict requirements for cleanliness demanded by modern clean rooms.

In the past few months Rotronic have launched two new clean room panels that are as the name suggests designed specifically for use within clean room environments.

Our flagship product in the field is the CRP5 which we will take a look at first.

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CRP5 – Clean room From Rotronic

The CRP5 is a comprehensive clean room panel designed specifically for the requirements of modern clean rooms. Once installed the unit provides virtually no areas for dust to collect and the industrial glass front is extremely resistant to chemicals. With a fully configurable colour screen it is a stylish looking device!

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Unpacking the CRP5, the glass front, colour display and stainless steel fittings make the CRP5 elegant, easy to clean and functional

Internally the CRP5 delivers some serious capability, providing potentially a solution for all your clean room measurement and monitoring requirements. Including;

  • Differential Pressure via internal diaphragm sensor (measurement via rear ports and front ports for flexible instalation and calibration).
  • Interchangeable humidity and temperature sensor.
  • Two fully configurable analogue inputs (for particle counters, lux meters etc)
  • Two configurable switch inputs (for pressure or door switches etc)
  • 6 configurable relays (for alarm triggers)
  • Digital connectivity via RS485 and Ethernet (Modbus or direct connection to Rotronic HW4 software)

A unique feature of the CRP5 is the optional flush mount humidity probe. The probe is locked into place through the use of magnets and can easily be removed for cleaning or calibration. An optional rear mount connection is available for Rotronic HC2 humidity and temperature probes should you wish to monitor ducts or spaces remote to the CRP5 itself.

CRP2
The unique removable Humidity and Temperature probe for ease of cleaning and calibration

The configurable colour display shows alarm conditions which can be acknowledged via the front panel. Alarms can be used to trigger relays associated with audible and larger visitual alarms. Interaction with the CRP5 is via four optical buttons –  their use is completely unaffected if operators are wearing protective gloves or not (unlike capacitive interfaces).

CRP3
Optical buttons can be used easily even when wearing gloves!

As an FDA and Gamp5 compliant device the CRP5 is a safe choice for regulated industries. The instrument can be used with 3rd party systems via its analogue outputs or industry standard Modbus TCP / RTU communication. Alternatively the CRP5 can be connected to the Rotronic HW4 software package to provide a one stop solution for monitoring, control and alarming. Pharmaceutical validation services as well as ISO 17025 (UKAS) calibrations are available from Rotronic if required.

To get some more detailed information about our clean room solutions give us a call or visit our website… Rotronic Website and CRP5 Datasheet

Next time we will look at the Rotronic CRP1 a dedicated temperature and humidity clean room panel for  applications with slightly simpler requirements but still demanding a clean installation  and high accuracy measurements!

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The CRP1 – Humidity and Temperature measurements in clean rooms.

Dr Jeremy Wingate
Rotronic UK

Why do we need Warehouse Mapping?

Rotronic is proud to be able to offer an increasing range of products and services to meet the demands of our customers. The requirements for mapping especially thermal mapping are increasing dramatically in food, pharma and cosmetics production and transport industries.

But what is Thermal Mapping?
Mapping is the process of determining the temperature and often humidity gradients within a defined space. It is a vital process when the product is regulated by government agencies such as the US Food & Drug Administration (FDA) or the European Medicines Agency (EMA). Regulated materials must not exceed strict storage conditions. Fixed limits will typically exist for humidity and temperature both in terms of the absolute value and also the allowable rates of change. Mapping serves as a baseline for proving compliance within the storage spaces.

The reason for increasing regulatory compliance is to ensure products do not spoil or otherwise degrade during production, storage and transport. Warehouses are notorious for having warm or cold spots that are outside of the regular control specification. A proper mapping study serves to locate these spots and either modify or avoid the problem area. Similar problems can occur during transportation so increasingly transport is at least monitored if not fully controlled and mapped.

At 4.3 million square feet, the largest warehouse in the world is the Boeing Everett factory in Everett, WA USA. It was originally designed to construct the Boeing 747.

An FDA Form 483 is issued to a company’s management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Mapping in General
A mapping strategy is needed for several reasons. It is important for regulators or quality managers to understand the philosophy employed for the mapping. A documented strategy will decrease questions from any regulators reviewing your mapping study. The strategy document also helps them understand the data that is produced by the mapping process. The document acts as a tool for collaboration as other people may suggest ideas that will make your study produce better data or make your effort more efficient.

As the mapping study progresses from start to finish, the strategy document acts as your reference guide, ensuring you remain true to the agreed upon process and do not make changes that will negatively affect the study. A typical strategy is usually comprised of a few written paragraphs that includes a description of the warehouse space, the type of equipment used, the number of sensors to be used, a general idea of the sensor placement, and the duration of the study. It is not unusual for the mapping strategy to change as it evolves. Writing a detailed document at the early stages of the project may cause re-writes that can increase the total length of the project. It is usually more efficient to fully document the warehouse mapping project after the strategy is agreed. Think of the strategy document as a proposal for your mapping team or the approval team so they can buy into and understand your mapping strategy. It may also facilitate the final approval stage, later in the project, because the auditor already understands the warehouse mapping project.

Continuous Monitoring After the Warehouse Mapping
Continuous monitoring is a best practice within controlled and regulated spaces. The mapping study will determine the hot and cold zones for “worst case” sensor placement. These worst case locations should be considered when installing a permanent, continuous monitoring system. The number of sensors used for a permanent system will be far fewer than what is required for the mapping study. In some cases, continuous monitoring may require only a few sensors once the problem areas have been determined through the mapping study. A continuous monitoring system offers peace of mind as product components, manufacturing space, or storage space are maintained and on record as meeting specified environmental conditions.

If you have any queries regarding warehouse mapping feel to get in touch and we will be happy to discuss!

Dr Jeremy Wingate
Rotronic UK

Rotronic training course schedule 2016

We are pleased to announce our latest training course schedule for 2016. Courses include in partnership with Dave Ayres from Benrhos Ltd our practical 3 day temperature, humidity and dew point calibration and measurement uncertainty courses. In addition, for those seeking greater depth we are running dedicated courses on measurement uncertainty and ISO 17025 run by Lawrie Cronin and Dave Ayres

Temperature Humidity and Dew Point – Measurement, Calibration and Uncertainty

8th – 10th March :: 12th – 14th July :: 15th – 17th November
– Three day course at Rotronic UK offices and UKAS laboratory
– Practical applied knowledge and best practice
– Max 8 attendees to ensuring tailored content

Measurement Uncertainty for Laboratories and Plant

6th – 7th September
– Two day course at Rotronic UK offices
– Detailed knowledge for laboratory owners or process managers

Setting up and working with ISO17025

8th September
– One day course at Rotronic UK offices
– Ideal for ISO17025 lab managers or those looking to apply

For further information please do not hesitate to contact us.

 

Holiday video! – Growth of snowflakes

For those of you working to the bitter end of this holiday season, why not take 5 minutes to relax and watch some of these amazing time lapse videos of the growth of snowflakes.

Whilst here in the UK we may not really have the weather for snow at the moment except on the higher hills, snowflakes are part of Christmas.

Snowflakes form as water vapor changes phase straight from gas to solid skipping the liquid phase. The solid ice crystals will form around a nucleation point – typically a small particle in the air or on a surface.

snowflake2

Just like a droplet of water forming during condensation more water vapour collects on the embryonic crystal allowing it to slowly grow, slow is the key to allow the crystal shape to develop the intricate designs and shapes. Ice lattice physicals typically dictate that a snowflake will have a hexagonal structure at its core. The common stella dendrite snowflake has is recognised for its beautiful 6 branched form. This is created simply through random crystalisation from the original hexagonal core. Each individual arm grows independently but each arm is exposed to the same environmental conditions resulting snowflakes which can appear to have incredible symmetry.

So enjoy a few minutes relaxing watching these mesmerizing videos!

Finally may we wish you well for the holiday season and peace and prosperity for 2016

Jeremy Wingate
Rotronic UK