ACCUTEK calibration services offer in house & on site calibration services as per requirement of ISO/ GMP/cGMP/ WHO/MHRA & FDA. ACCUTEK provide best of services with highly accurate and reliable master instruments directly traceable to national standard ERTL (Electronic Regional Test Laboratory) & IDEMI (Institute for design of Electrical Measuring instruments) Mumbai to cater to the needs of calibration that is done at the customer’s promises. ACCUTEK is well known for its quick work execution, delivery, reliability & economical rate structure. ACCUTEK always keep our customer up to date with technical and regulatory developments
PLC Validation is becoming Very Essential / Mandatory for the Life Science Companies as Current GAMP 5 Regulation are becoming very stringent. It is now a big challenge for Pharmaceutical Companies to Install & Maintain fully Automatic Systems for different stages of Production in a Fully Compliant Manner. Here we can support you with our Vast Experience in this field. We validate your Systems in Cost Effective Manner to ensure all Predicate Rules are satisfied with Proper Documentation of Complete Activity.
We offer validation to PLC systems for companies in various industries for upgrading their existing systems with new PLC platforms. Our PLC validation systems comply with current standard, regulations and quality processes. Our validation process is ideal for I/O cards installed more than 30 years ago and enables them to connect with newest automation technologies. Our validation process preserves customer investments in system validation while facilitating the upgrade of processors, I/O and other components of process automation systems.
✔ Testing Of PLC Processor
✔ Testing Of PLC Input / Output List
✔ Testing Of System Security
✔ Testing Of Programmable Function Keys,Command Buttons,Displays and Set Parameters
✔ Verification Of Environmental Conditions
✔ Testing Of Power Failure Conditions
✔ Testing Of Communication Failure Conditions
Quality of Final Product is depending on the Proper & Efficient Working of Instruments used at different stages in the Manufacturing Process. The accuracy of the electronic components used in all Instruments naturally drifts over time. Time in service as well as environmental conditions also add to this drift. As time progresses, changes in component properties will cause grater uncertainty in your measurements. Eventually, the drift causes the Instruments uncertainty to become undefined, meaning the manufacturer can no longer predict the uncertainty and guarantee measurement results. To resolve the issue, Instruments must be calibrated at regular intervals as defined by the manufacturer.
All our Masters Instruments are of Reputed Manufacturer, Very Accurate & Reliable. We are doing periodic Calibration of our Master Instruments from NABL Accredited Labs. We are carried out Calibration at Client’s Site. We are following all standard norms while carrying out the Calibration Activity. Our Calibration Services are already audited by various reputed Pharmaceutical Companies. We maintain proper documentation of the calibration activity like SOP, Raw Data Sheets, and Calibration Certificate. We are giving NABL Traceability for our Calibration Certificates.
➤ Aim of calibration services
• To record the data against master instruments at given time interval.
➤ Important Elements of a calibration services
• Technical Competence
• Up-to-date metrological hardware
• Calibration hierarchy
• Appropriate environment
• Presence of documented quality system
➤ Frequency of calibration
• Manufacturers recommendation
• Trends of previous calibration
• History of maintenance and servicing
• Handling and storage conditions
• Extent and severity of use
➤ Parameters of calibration
• Temperature Sensor / Element / Gauge / Psycronmeter/Thermometer
• Transmitter / Indicator / Controller/Chart recorder/Thermostat
• Pressure / Vacuum Gauge, Transmitter & Switch
• Pressure Safety Valve, Control Valve, I/P Converter
• Magnetic Differential Pressure Gauge/Manometer
• Data Logger / Recorder / Temp. Scanner
• Level Transmitter & sensor, UV Meter & Sensor,
• pH, & Conductivity Sensor & Transmitter
• Timer, RPM Indicator, Stop Watch, Anemometer, Lux Meter,
• Humidity Sensor, Meter & Data Logger (Hygrometer)
• Multimeter, Clampmeter, Amperemeter, Voltmeter
• Vernier Caliper,Micrometer,Depth Gauge,Dial Gauge,Scale
• Flow Meter, Rotameter
From 1st October 2008 all member states of CEN (European Committee for Standardization) who use steam in any moist heat sterilization application will be required to test the steam for non-condensable gases, superheat and dryness value.
Documentary evidence that the sterilizer complies with the requirements of the European standard will need to be established, maintained and declared. The steam supply required for moist heat sterilization needs to be within the specifications set out in EN285:2006. This is:
Non-Condensable Gases: Required Result = 3.5%
Air and other gases such as Carbon Dioxide, which do not condense under the conditions of steam sterilization.
Superheat: Required Result = 25ºC
Superheat steam is a steam at a temperature which is greater than its boiling point for its pressure. It will not condense until its temperature drops to its boiling point and until this occurs the moisture required for sterilization cannot be produced.
Dryness Value: Required Result = 0.90: = 0.95 for Metal Loads
Wet steam can cause wet loads which in turn can be considered un-sterile. In today’s world, confidence of sterility is paramount. Modern packaging prevents re-infection when dry but bacterial retentive properties will be dramatically affected by the presence of moisture. A value of 1 represents steam that is completely dry and free of moisture.
ACCUTEK’s recent diversification is in the field of Energy Audit. The issue of energy consumption has been a growing interest across all industry sectors not only because of its immediate impact on production costs but also because of its considerable impact on environmental sustainability. An improvement in energy efficiency within your organization can potentially bring significant business benefits.
Our audit provides you with a clear understanding of energy consumption in your plant and facilities. Quantitative findings can provide substantial practical guidelines for:
• Continuous improvement in production efficiency
• Identifying cost saving opportunities in energy efficiency
Starting with the development of an energy consumption inventory, detailed auditing activities will be conducted to identify buildings and facilities with particular focus on rationalizing their energy profiles. Following the establishment of an energy consumption profile, the potential energy saving opportunities can be identified. The Energy Audit will be conducted as per following steps:
1. Monitor & Access
2. Reduce Energy Consumption
3. Retrofit or Replace inefficient loads.
4. Alternate Generation Product.
Temperature / Humidity Mapping are Very Critical Step in the Validation of any Pharmaceutical Process. To ensure the Safety and Efficacy of Life Science Products, all Storage and Manufacturing Facilities (From Raw Material to Finished Goods) must be Temperature / Humidity Mapped to show that Storage and Transportation conditions are good for your Products & meeting all Regulatory Requirements.
We provide high quality Qualification Services for Equipment & Facilities. Our experience in Temperature / Humidity Mapping allows us to offer our customers a wide range of services. We can help our customers to established methods & Protocol based on current GMP Trends and best practices followed in Industry.
We have proper Documentation methods meeting Current Regulatory requirements. Our Documents consist of Basic Temperature Mapping Data, Calculations like F0, Fh, Min. & Max. Temperature, Standard Deviation, Lag Time Calculation, Identification of Hot & Cold spots, we also provide Graphical Presentation of Temperature V/s Time, Diagram Indicating Sensor location & Validation Summary / Certificate etc.
➤ Our range of services in Thermal Validation
• Autoclave, DHS, Depyrogenation Tunnels, Ovens
• Warehouse, RM Stores, Labs, Production Area
• Stability Chambers, Refrigerators, Freezers, Incubators, Cold Chambers
• Vessels, Tanks, Filters, Fermentors
• Water Baths, Muffle Furnace, Vacuum & LOD Oven, Other QC Equipments.
With our state of art equipments and procedure and documentation in compliance with the international standards, we can systematically carry out clean room validation with the help of our sister concern M/S. AIRWINZ ( CLEAN ROOM VALIDATION AGENCY INDIA) like Pressure Balancing, Air Velocity uniformity test, DOP/PAO Test for HEPA, Particle Count Test, Recovery Test, Air Flow Patter test with video graphy and produce the best documents without any error.
Clean room HVAC Validation (New Installation and Re-qualification)
With our state of art equipment’s and procedure and documentation in compliance with the international standards Like ISO 14644 -1 – 6 and EU GMP, cGMP, we systematically carry out clean room validation like
1. Air Velocity Test
2. HEPA Filter Integrity Test (Using DOP/ PAO)
3. Particle Count Test (with UCL Calculation)
4. Recovery Test
5. Air Flow Pattern Test (DI / Glycol Smoke as per ISO 14644)
6. Temperature Humidity Monitoring/ Mapping.
7. Sound Level Testing
8. Light Level Testing.
9. Vibration Testing
We have well established Protocol / SOP and all our instruments and equipment’s are calibrated with international traceability. And have very unique Certificates formatting which ensure clarity of data without any error.
Compressed air is used in a wide range of industries like medical, pharmaceutical, food/beverage etc during manufacturing, packaging of products and various other applications.
ACCUTEK conducts Compressed Air/Gas Testing as per ISO 8573 and other National, International and Industry Specific Recommendation like GMP, ISPE (International Society for Pharmaceutical Engineering) to evaluate the contaminants such as particles, water, Oil, mist, Volatile Hydrocarbons, microbiological contaminants and other gaseous contaminants.
ACCUTEK also undertakes the test as per the client’s specifications to meet their customized requirements. Our team conducts an array of tests to ensure that the air meets the standards required in hospitals, pharmaceuticals & other industries which makes use of compressed air/gas.
Our services include testing for:-
• Oil Aerosol contents
• Humidity/ Dew point
• Solid Particle
• Oil Vapor and Organic Solvents (Hydrocarbons)
• Gaseous Contaminant
• Liquid Water
• Oxygen constraints