Biolinx evaluates instrument with its CHECK LIFE PLAN of instrument by comprehensive analyses, evaluation, repair, calibrate, validate and functional assuring your investment and without hampering productivity by eliminating unscheduled downtime and optimising your operations. And all that at lowest cost and peace of mind but with profession and uncompromised solution!!
To assist customers in meeting peak demands, unexpected situations or evaluations and also to minimize downtime of important processes, we offer an array of measurement, test and calibration equipment on a short or long term rental basis.
We are committed to providing our customers with the highest quality of repair services for all freezers and refrigerators for any make/brand. Already repaired successfully 100+ units of different brands and models
We offer Silver and Gold Equipment Maintenance and Repair programs designed to meet your critical calibration and maintenance needs.
We support the preventive maintenance of your lab and process equipment as required be the EMA, FDA, and ISO. Our PM Documentation has a proven track record and has helped our customers through many regulatory and customer audits with no major findings.
Our preventive maintenance service is designed to improve your equipment performance and ensure it remains in proper operating condition. Our PM documentation is audit ready and service due dates are tracked for recurring service calls.
On-Site Preventive Maintenance Capabilities:
- Automated Glassware Washers
- CO2 Incubators
- -20C Freezer
- -80C Freezer
- Stability Chambers
- and more…
We maintain laboratory accreditation of NABL, with operating procedures to comply for WHO, USFDA, CGMP AND all major international guidelines for parameters like TEMPERATURE, TIME, RELATIVE HUMIDITY, PRESSURE & VACCUM, AIR BOURNE PARTICLES,FLOW OF AIR VOLUME, ROTATIONS PER MINUTE(RPM), pH, CONDUCTIVITY, STERILIZATION, Centipose, CO2, Conductivity, Differential Pressure, Dimension, Force, Humidity, Mass, pH, Pressure, Rotation, Speed, Temperature, Time, Torque, and more…
The Installation Qualification & Operational Qualification Protocol defines a set of procedures to ensure that our equipment is properly installed.
Installation and operational qualification as well as supporting Performance Qualification (PQ) documentation. We designed our validation service platform to be customizable for our customers’ many unique and custom processes. We deliver validation services and documentation that demonstrates our customers have “established evidence that provides a high degree of assurance that their process consistently produces product which meets pre-determined specifications and quality attributes”.
Our on-site validation service team travels the US nation-wide and is capable of processing thousands samples supporting our documentation and providing our customers with evidence that their process is capable of meeting its end-point accurately and repeatedly.
On-Site Equipment & Process Validation Service Capabilities:
Equipment Validation Services-
- Autoclave Validation
- Fume Hood Validation
- Glass Washers
- Laminar Flow Hood Validation
- Manufacturing and Process Equipment
- Packing Equipment
- Sterilizer Validation
Process Validation Services-
- Aseptic Techniques
- Batch Transfers
- Cleaning Validation
- Gowning Validation
- Label Validation
- Packing and Shipping Validation
- Sterility Validation
We use the best in quality industry-standard validation equipment, to provide you with reliable and repeatable results on every temperature mapping validation project. Our vast array of mapping validation equipment allows us to provide our customers with a large variety of options when choosing how many data-points and parameters they want to include in their temperature mapping validation study.
Our validation engineers work onsite directly with your team and provide easy to follow validation binders and protocols at the end of each project. The final validation binder is designed to provide you with sufficient data allowing you to determine if your Warehouse or Walk-In is operating properly and meeting your control specifications.
Our Compliance Service Division offers a broad range of services for your Facility’s Calibration & Maintenance Management System (CMMS). Biolinx engineers can be staffed either part-time or full-time, offering onsite “Tech-Staffing” support options for auditing, building, maintaining, and/or updating your Calibration/Maintenance Database.
We work with small startup labs and large established corporations to build new Calibration Programs from the ground up or transition from existing basic needs programs to more comprehensive calibration – maintenance databases.
- Draft a Project Plan
- Establish Minimum Requirements
- Submit Process Flow Maps
- Draft Program SOPs
- Walk-Down Facility
- ID Equipment Included & Excluded
- Build Cal-PM CMMS Database
- Validate Procedure Workflows
- Refine and Implement
- Measure Effectiveness
- Provide long-term support for sustainable compliance
Our Compliance Engineers and Quality Associates are certified by Blue Mountain and have extensive experience with Cal-Man, RAM, ProCal, MetCal, & other Custom Calibration & Maintenance Management Systems. We can help you update equipment service history, investigate out-of-tolerance issues, establish criticality, and develop key metrics for reporting the health and sustainability of your Calibration Program