Pharmaceutical Manufacturing

Pharmaceutical Manufacturing Calibration Services

In pharmaceutical manufacturing, compliance with regulatory requirements, such as Good Manufacturing Practice (GMP) regulations, necessitates using calibrated instruments and equipment throughout the manufacturing process to ensure product quality, safety, and efficacy. Regular calibration, proper maintenance, and validation procedures are essential to maintaining the accuracy and reliability of manufacturing systems.

With the help of Transcat services, you can gain the trust of regulatory authorities, healthcare professionals, and consumers. Our calibration and validation services are tailored to pharmaceutical manufacturers' needs and compliance requirements.

Compliance regulations govern every aspect of pharmaceutical manufacturing including production, labeling, distribution, clinical trials, and more. Here are a few areas where calibrated tools and instruments are critical. 

• Pharmaceutical Production  
  The equipment used for pharmaceutical production is required to be calibrated to produce high-quality, and uniform products. Transcat Pharmaceutical Validation Services not only manages calibrations to GMP requirements but also offers expertise in conducting validations for regulated process equipment such as:  
  
  • Formulation and Compounding - balances, volumetric glassware, and liquid handling devices
  • Granulation and Compression - tablet presses and granulators
  • Mixing and Blending - blenders, mixers, granulators
  • Coating - pan coaters and spray systems.
• Quality Assurance Testing 
  Instruments used for analytical testing of raw materials, in-process samples, and finished products require calibration to ensure accurate and reliable test results. This includes chromatography systems (HPLC, GC), spectrophotometers, dissolution testers, pipettes, pH meters, and moisture analyzers. 
• Cleaning and Sterilization 
  Cleaning validation studies are necessary to demonstrate compliance with cleaning procedures on equipment to prevent cross-contamination. This validation requires instruments such as calibrated swab testers and rinse water analysis systems to ensure accurate detection and quantification of residues. 
  Autoclaves, sterilizers, and depyrogenation ovens used for sterilizing equipment and containers also require calibration to ensure proper temperature, pressure, and time parameters for effective sterilization.  
• Packaging and Labeling 
  The instruments that monitor and control packaging and labeling processes require calibration to prevent errors and ensure compliance. For example, pipettes require calibration for precisely dosing liquid formulations into vials, ampoules, syringes, or bottles. Cartoners, labelers, and blister packing machines also require calibration to ensure proper sealing.  
• Temperature Control 
  Test samples often require storage within temperature-controlled environments from simulating extreme temperatures to growing cultures. Transcat Equipment Validation Services verifies that laboratory equipment performs to the manufacturer’s specifications. This includes specialized services for incubators, stability chambers, freezers, refrigerators, and cold rooms.  
• Environmental Monitoring  
  Instruments used for environmental monitoring within manufacturing facilities, such as temperature and humidity loggers, particle counters, and air samplers require calibration to ensure accurate monitoring of controlled environments. Environmental monitoring data is used to demonstrate compliance with cGMP compliance requirements for cleanroom conditions and air quality standards. For storage applications, Transcat offers a Warehouse Temperature Mapping Validation Service to ensure perishable products are stored safely. 

Pharmaceutical, Medical Device, and Laboratory Validation Services 
These specialized validation services provide documented evidence that your systems, facilities, and processes perform their intended functions according to specifications set by the FDA or custom protocols. Service options through NEXA | EAM, a Transcat Company, include qualification of new installations, validation, revalidation, and instrument calibration. 

Pipette Calibration and Supplies 
Transcat Pipettes offers 3–5-day turnaround for pipette calibration services and as fast as 24-hour turnaround within defined service areas. We are also a multi-brand distributor of high-quality pipettes, pipette tips, and benchtop equipment.  

Enterprise Asset Management (EAM)    
NEXA | EAM, a Transcat Company, provides technical, consulting, and staffing solutions to improve asset management programs for life science industries in North America, Europe, and Asia Pacific. Asset management services include calibration, maintenance and spares, reliability, CMMS, quality, compliance, and CQV services. 

Instrument Metrology and Repair Services 
Transcat Biomedical is a leading, national provider of quality instrument metrology and repair services. Our services are available on-site or from one of our ISO 17025-accredited biomedical labs. 

Test & Measurement Instruments  
We offer a wide range of types and brands of test & measurement Instruments to maintain the productivity, accuracy, and compliance of your manufacturing systems. We are your one-stop shop for buying, renting, and obtaining expert calibration.  

For more information about our accredited calibration and validation services for pharmaceutical manufacturing applications, call one of our calibration professionals at 800-828-1470 or contact us.