S V Controls provides sustainability solutions for the Life Science industry
Solutions & Services
Modular, scalable solutions from lab to pilot to full production
From simple loop control to information integration and plant wide EMS/FMS/BMS systems, you can choose modular solutions to match your application and budget. As your requirements grow, new modules can be easily incorporated into your system.
A Life Cycle Development approach based on GAMP4 provides you with consistent control and quality worldwide. This approach results in a reduction of potential validation costs and provides full control and traceability throughout your project life cycle.
Electronic Data Recording
A range of products designed to acquire your process data
and then to display, transfer and manage that data using
secure yet flexible means to meet your needs.
- Comply to 21 FDA CFR Part 11 Regulations for
Electronic Records and Electronic Signatures
- Multi-batch recording
- Range of Ethernet protocols available
- Standard networking via Ethernet
- Math capability including Mean Kinetic
- Temperature (F0) calculation
- Web server via Bridge software
- Time Synchronization
- Offline data viewing via Reviewer software
- Report generation
- Direct printer output
- Email/SMS alarm/event notification
- Proven Ready to Use Templates for
ISPE GAMP® 5 Qualification/Validation
operations (Cat3 for product, Cat4-5 for Solution)
Plant wide Data Management
The Information Manager combines the power and flexibility
of a relational database with the speed and compression of a
real time historian package.
- Capture and stores all plant data.
- Real-time and historical plant information accessible
to the entire organisation
- Embedded Microsoft SQL Server provides standard
- SQL queries
- Based on Aveva Industrial SQLServer real-time plant historian
- Comply to 21 FDA CFR Part 11 Regulations for Electronic
Records and Electronic Signatures
- Client Server architecture (redundant in option)
- Proven Ready to Use Templates for ISPE GAMP® 5 qualification/Validation
operations (Cat3 for product, Cat4-5 for Solution)
- Report generation
- Data Analysis/ Data Analytics
who are fully knowledgeable and experienced in Life Science
applications and in working within the specific constraints
of this market.
They include qualified project management professionals (PMP)
who are also fully trained and experienced in working to the
ISPE GAMP®5 guidelines.
From collecting the information on site to interacting
with suppliers and 3rd parties, we are able to engineer
your automation project, to start up your production
line and ultimately to provide you a lifetime support
contract ensuring you kept aware of the evolution of
technology and of any possible enhancements to your
installation, Faster, Better, more cost-effective.
Field Service, Help Desk and technical support are
there to assist you.
Our field service teams provide much more than an on-site
breakdown service. We are also able to assist with commissioning,
training, process improvement and routine maintenance.
Each engineer has been factory trained, provided with tested
and verified calibration equipment, and also carries an extensive
range of both spares and new instrumentation.
Our engineers are also trained to complete their activities
within the discipline and requirements of Validated plant,
equipment and processes and to suitably record all the
necessary changes and re-validate as and where necessary.
We can manage for you the Change Control of the
Qualification/Validation documents related the
ISPE GAMP®5 guidelines.
During commissioning or upgrade, a small amount of technical
support by our engineers could save your own staff a great deal of time.
Our Technical Support team can also provide additional application
advice over the phone or by email. This service is available to you
by the hour or by the day or from a Service Level Agreement contract,
and additional time can be ‘banked’ for future requirements.
This is in addition to technical support time ‘built-in’ to many
Eurotherm products at the time of purchase.
Most businesses are driving down hard on CAPEX and OPEX costs
and striving to improve performance. Eurotherm play a role in this
process by bringing experienced engineers onto site, auditing the
process and identifying possible improvements.
Monitoring equipment can be installed to understand performance
and costs, to create a baseline upon which the improvements can be
The solutions will range from simple enhancements, re-commissioning
or possibly taking a completely fresh approach from the control solution
to Advance control solution (involving possibly IA technology).
Typically this work is only completed when new projects are
undertaken but we believe it can improve the productivity of
plant by applying the experience of our engineers on the
day by day basis.
Our Team is of more than 60 engineers and technicians
who are fully knowledgeable and experienced in Life Science
applications and in
working within the specific constraints of this market.They include
qualified project management professionals (PMP) who are also
fully trained and experienced in working to the ISPE GAMP®
5 guidelines. From collecting the information on site to interacting
with suppliers and 3rd parties, we are able to engineer your
automation project, to start up your production line and ultimately
to provide you a lifetime support contract ensuring you kept aware
of the evolution of technology and of any possible enhancements to
your installation, faster, better and more cost-effective
Our engineers can also assist in creating your User Requirement
Specification (URS) in compliance with the ISPE GAMP® 5 guidelines,
following a comprehensive analysis of your processes and Risk based
methods, together with an understanding of your business requirements
and your expectations.
Life Science Expertise
Our project Engineers delivered already lot of projects in the regulated
context of the Pharmaceutical, Generic, Biotech and Medical devices environment. They are trustful and great adviser based on their knowledge
and experience, they are ready to talk with you, to audit your process on
DATA INTEGRITY (ALCOA (+) concept), Qualification and Validation
perspective (ISPE GAMP® 5 ). Let us know, how we can help you ?
Network and Cyber security Analysis
Networks and Cyber security are the back bone of today’s control and
monitoring systems, transmitting process data between devices, local
controllers and supervisory systems. Their failure can clearly have
a serious impact on plant systems.
Using specialist equipment, our engineers will create a report
detailing the physical and electrical qualities of the network.
The quality and utilization performance, capacity and architecture
will be measured and assessed. The physical failures, bottlenecks
and the overall capacity of the system will be identified.
This analysis will result in a clearer understanding of your network,
reducing downtime and improving performance.
Global Agencies such as WHO (World health Organization),
FDA (Food and Drug Administration), EMA
(European Medicine Agency) , Association such as
PIC/S (Pharmaceutical Inspection Co-operation Scheme),
ISPE (International Society for Pharmaceutical Engineering)
established a consensus on the DATA INTEGRITY guidance to
manage the Electronic record in the Life Science Market.
Data Integrity is an important part of any production quality
requirement on the GMP (Good Manufacturing Practice)
Therefore, in regard to the ALCOA (+) concept argument
“ACCURATE” and “CONSISTENT” loss of any data resulting
in gaps in the historic information is not acceptable for any
production batch and any measurement on the Environmental
Typically, long-term historian data is written to a computer server,
but loss of communications with a measuring device can cause a
loss of data in production batch or on the Environmental
Monitoring System. The concept of Store and Forward eliminates
these gaps in the collected data by using the Historical Raw Data
and Audit Trail stored locally on a measuring device.
The local historical Raw Data, Meta-Data and Audit trail are
forwarded to the Historian server and used to replace any gaps
in collected data by extracting data contained in the Tamper
Resistant recording (.uhh) files and writing it to the database.
“Store & Forward” is a self-healing archiving system that
automatically stores data during a communications failure and
then forwards this to the configured server when communications
have been reinstated.
This results in Tamper Resistant electronic recording with
total DATA INTEGRITY (compliant with the FDA 21CFR Part11).
- Process value and audit trail sent directly to Central
Historian such as Eurotherm INSQL
Missing Data in Historian caused by
- Communications failure
- PC Failure
- Historian Failure
Store, Forward and Backfill Action
- Identify missing data period
- Retrieve data from Tamper Resistant recording (.UHH)
directly from the Eurotherm Device
- Device ATTRIBUTABLE backfill the control Historian with
PAC T2750 provides
- Dual Redundant Data Acquisition
- Secure .UHH created and stored at local level
6000 Recorder series and nanodac provides
Tamper Resistant recording (.uhh) created and stored at
Opto 22 Groov EPIC
Atex compliant by standard solutions, completely IIOT enabled and cyber secure control system. This syatem is equipped with MQTT, Node-Red and SSH.
Applications of Life Science
The Spray Drying Process
Earliest descriptions date from 1860 with the first patented design recorded in 1872. The basic idea of spray drying is the production of highly dispersed powders from a fluid feed by evaporating the solvent. This is achieved by mixing a heated gas with an atomized (sprayed) fluid of high surface-to-mass ratio droplets, ideally of equal size, within a vessel (drying chamber), causing the solvent to evaporate uniformly and quickly through direct contact.
The Freeze Drying Process
The product is usually in phials placed on shelves in a vacuum chamber, which is first frozen and then evacuated. The shelves are then warmed up very slowly, boiling off the liquid, whilst the chamber is continuously evacuated through a cold condenser.
The Hydrogenation Process
Hydrogenation may be either destructive or non-destructive. In the former case, hydrocarbon chains are ruptured (cracked) and hydrogen is added where the breaks have occurred. In the latter, hydrogen is added to a molecule that is unsaturated with respect to hydrogen. In either case, the resulting molecules are highly stable.
The Tablet Coating Process
Either on the external surface of tablets, or on materials dispensed within gelatine capsules. Coating serves a number of purposes:
Protects the tablet (or the capsule contents) from stomach acids
Protects the stomach lining from aggressive drugs such as enteric coated aspirin
Provides a delayed release of the medication
Helps maintain the shape of the tablet
Ideally, the tablet should release the material gradually and the drug should be available for digestion beyond the stomach. The coating can be specially formulated to regulate how fast the tablet dissolves and where the active drugs are to be absorbed into the body after ingestion.
Many factors can affect the end-use properties of pharmaceutical tablets:
Storage and environmental monitoring
Environmental monitoring system
The Eurotherm Environmental Monitoring System aims at helping to achieve a rigorous approach to managing and improving the environmental aspect of operations required by the ISO 14001 international standard for environmental management systems.
In order to achieve this, the Eurotherm EMS application module provides you with the information and functionality needed to capture the system behavior and make environmental investment effective.
The Water Purification Process
Suspended or dissolved particles, organic compounds, impurities and other contaminants prohibit the usage of tap water in laboratory applications and scientific research. Parameters such as resistivity, conductivity, size of particulate matter and concentration of microorganisms are used to categorize water quality and, therefore, specify intended uses for water. Some applications can tolerate the presence of specific impurities in the water, but others, such as High Performance Liquid Chromatography (HPLC) require removal of the majority of contaminants.
The Sterilization Process (Autoclaves)
Heat generated through application of high temperatures acts by disrupting membranes and denaturing proteins and nucleic acids. Burning, however, is a bit excessive for everyday usage.
Transmissible agents (such as spores, bacteria and viruses) can be eliminated through sterilisation. This is different from disinfection, where only organisms that can cause disease are removed.
Ethylene Oxide (EtO) Sterilization Process
Ethylene Oxide (EtO) sterilization is mainly used to sterilize medical and pharmaceutical products that cannot support conventional high temperature steam sterilization – such as devices that incorporate electronic components, plastic packaging or plastic containers.
EtO gas infiltrates packages as well as products themselves to kill micro organisms that are left during production or packaging processes. This gas, mixed with air at a ratio of at least 3% EtO gas, forms an explosive mixture. Pure EtO gas boiling point is 10.73 ºC at atmospheric pressure. Most of the time, it is mixed with Nitrogen or CO2. This explosive condition requires Intrinsic Safe material (ATEX) zoning, for security of people as well as security of the process itself.
Environmental and Stability Chamber Monitoring
The FDA and other regulatory bodies require not only accurate measurement and storage of room parameters but if the storage medium is electronic then the methods used must comply with FDA 21 CFR Part 11.
Stability Monitoring of medicinal products is an area also addressed by the ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use) and the ICH final guidance (agreed Feb 2003), is now being adopted across Europe, Japan and the United States.
The FDA also states in its 21 CFR part 203 section that manufacturers, authorized distributors of drugs and their representatives shall store and handle all drug samples under conditions that will maintain their stability, integrity and effectiveness, and ensure that the drug samples are free of contamination, deterioration and adulteration.
The Fermentation Process
It requires the cultivation in submerged culture of an identified micro-organism (mainly bacterial) as a monoculture under defined environmental conditions. The incubation regime imposed is designed to maximize the productivity of the organism of interest by providing optimal conditions for population growth (biomass). The product of interest might be a bioactive metabolite or recombinant protein.
During an incubation cycle a nutrient energy source (e.g. glucose) is added and the biomass and end product will increase as this is depleted.
T2550/T2750 Data Logging Creating Flexible Solutions
Electronic logging of process values
Designed for FDA 21CFR Part 11 electronic records
FTP push to up to three servers
SNTP time synchronization across the network
A unique feature of the T2550/T2750 PAC is secure redundant data recording. This allows data, alarm information and messages to be recorded at the point of measurement, with all data being time stamped as it is recorded, satisfying regulations such as the FDA 21CFR Part 11 or Nadcap and the DATA INTEGRITY ALCOA (+) guidelines.
Complete BMS and EMS Solutions
Control and monitoring of storage and production environments has become an important issue within the Pharmaceutical Industry. The FDA, EMEA and other regulatory bodies require accurate measurement and storage of room parameters and, if the storage medium is electronic, the methods used must comply with FDA 21 CFR Part 11.