Precision Calibration for the Pharmaceutical and Bioprocess Industries
In the pharmaceutical and bioprocess industries, maintaining stringent quality control and regulatory compliance is paramount. At International Process Solutions (IPS), we specialize in comprehensive calibration services designed to meet the demanding standards of these highly regulated sectors. Our expertise ensures that your equipment operates within required specifications, providing accurate and reliable performance essential for maintaining Good Manufacturing Practices (GMP) and regulatory compliance with organizations such as the FDA, ISO, and USP.
Why Calibration is Critical in Pharmaceutical and Bioprocess Operations
In pharmaceutical and bioprocess environments, even minor deviations in instrument accuracy can lead to compromised product integrity, failed regulatory inspections, and potential safety risks. Calibration is essential for ensuring:
- Regulatory Compliance – Adhering to FDA 21 CFR Part 11, ISO 17025, and GMP standards.
- Product Quality and Safety – Preventing contamination, batch inconsistencies, and deviations.
- Operational Efficiency – Reducing downtime and improving process reliability.
- Data Integrity – Ensuring precise measurements for reproducible and valid results.
Comprehensive Calibration Services by International Process Solutions
At IPS, we offer meticulous calibration services tailored to the unique requirements of pharmaceutical and bioprocess companies. Our services cover a wide array of critical instruments, including:
1. Temperature and Humidity Calibration
- Autoclaves and Sterilizers
- Environmental Chambers
- Cold Storage and Freezers
- Incubators and Ovens
- Hygrometers and Thermohygrometers
2. Pressure and Flow Calibration
- Manometers and Barometers
- Pressure Gauges and Transmitters
- Vacuum Sensors
- Flow Meters and Controllers
- Differential Pressure Indicators
3. pH and Conductivity Meter Calibration
- pH Sensors and Probes
- Electrolytic Conductivity Meters
- Turbidity Meters
4. Mass and Balance Calibration
- Precision and Analytical Balances
- Microbalances and Laboratory Scales
- Load Cells and Weighing Systems
5. Electrical Calibration
- Multimeters and Ohmmeters
- Temperature Controllers
- Signal Generators and Transmitters
- Data Acquisition Systems
6. Gas and Liquid Flow Calibration
- Flow Controllers for Gases and Liquids
- Rotameters and Variable Area Flow Meters
- Mass Flow Meters and Regulators
Regulatory Compliance and Quality Assurance
At International Process Solutions, we are committed to providing calibration services that not only meet but exceed regulatory standards. Our procedures align with:
- FDA 21 CFR Part 11 and Part 820 Compliance
- ISO/IEC 17025 Accredited Calibration Standards
- USP <41> and <1251> Weighing Compliance
- GMP and GLP Requirements
- NIST-Traceable Calibration Certificates
On-Site and In-Lab Calibration Services
On-Site Calibration Services
Our team of highly trained calibration specialists provides on-site calibration services to minimize equipment downtime. We offer:
- Rapid response times to meet production schedules.
- Minimal disruption to manufacturing processes.
- Comprehensive documentation for regulatory audits.
In-Lab Calibration Services
For more complex or sensitive instruments, we provide in-lab calibration services in our ISO-accredited facility, ensuring the highest level of precision and compliance.
Metrology Expertise and Cutting-Edge Equipment
Our calibration team consists of highly trained metrology experts who utilize state-of-the-art calibration standards and procedures. We employ advanced technologies such as:
- Automated calibration systems for precision and repeatability.
- NIST-traceable reference instruments for accurate measurements.
- Data logging and digital calibration reports to ensure transparency and compliance.
Tailored Calibration Programs for the Biopharmaceutical Industry
We understand that every pharmaceutical and bioprocess company has unique calibration needs. Our customized calibration programs ensure that:
- Scheduled calibrations align with production cycles.
- Preventive maintenance reduces downtime and extends equipment lifespan.
- Comprehensive record-keeping supports effortless regulatory audits.
Partner with International Process Solutions for Unmatched Calibration Services
Choosing International Process Solutions as your calibration partner ensures:
- Expert calibration technicians with extensive industry experience.
- Rapid turnaround times to maintain operational efficiency.
- Cost-effective calibration solutions without compromising on quality.
- Compliance assurance to meet stringent regulatory requirements.
We take pride in being the trusted calibration partner for leading pharmaceutical and bioprocess companies, delivering unparalleled accuracy, reliability, and compliance.
Contact Us Today
Ensure your pharmaceutical and bioprocess equipment remains accurate, compliant, and efficient with International Process Solutions. Contact us today to schedule your calibration services or to learn more about our customized solutions.
International Process Solutions Is Here For You!
We’re here for you at every stage of your growth, creating the exact solution you need. Reach out now – we’d love to help. Call Today 650-595-7890
Service so good – it will make you look great.
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