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Complete IQ/OQ/PQ validation for pharmaceutical processing equipment — Glatt, Ohara, ACG, Vector, and more. Audit-ready packages delivered.

IQ / OQ / PQFDA Submission ReadyGlatt · Ohara · ACG · VectorGMP Compliant
IQ / OQ / PQFull Protocol Service
FDA Submission ReadyAudit-Ready Packages
Glatt · Ohara · ACGOEM Equipment Experts
48-Hour TurnaroundOn Certificate Packages
OEM Equipment Validation

Equipment We Validate

We develop and execute IQ/OQ/PQ validation protocols for pharmaceutical processing equipment from all major OEMs — including those who refer clients to us directly for validation support.

Glatt Fluid Bed Validation
Glatt
Fluid Bed Dryers · GPCG · WST Series

IQ/OQ/PQ validation of Glatt fluid bed granulators and dryers. Temperature uniformity, inlet air velocity, exhaust control, spray system performance, and process reproducibility protocols.

Ohara Coater Validation
O'Hara Technologies
Labcoat · Fastcoat · Conquas

Full validation packages for Ohara tablet coating systems. Pan speed, inlet/exhaust temperature, air volume, spray rate, and coating uniformity qualification protocols.

ACG Fluid Bed Validation
ACG
FBC Series Fluid Bed Systems

Validation of ACG fluid bed systems with complete IQ/OQ documentation. Process parameter verification, thermal uniformity studies, and GMP-compliant reporting.

Vector Fluid Bed Validation
Freund Vector
FLO-COATER · Fluid Bed Processors

IQ/OQ/PQ protocols for Vector fluid bed and coating equipment. Temperature mapping, process verification, and audit-ready validation packages.

High Shear Mixer Validation
High Shear Granulators
Zanchetta · Diosna · Collette

Validation of high shear wet granulation systems. Impeller speed, chopper speed, temperature, load cells, and process endpoint verification protocols.

Tablet Coater Validation
Thomas Engineering
Accela-Cota · Hi-Coater

Full validation programs for Thomas tablet coaters. Inlet/exhaust air qualification, pan speed verification, spray system performance, and GMP documentation packages.

Validation Framework

IQ / OQ / PQ Protocols

We develop, execute, and deliver complete validation packages. Every protocol is written specifically for your equipment and facility — not generic templates.

Installation Qualification
IQ — Verify It's Built Right

Confirms the equipment is installed according to manufacturer specifications and your facility requirements. We verify utilities, components, documentation, and safety systems.

  • Equipment identification and component verification
  • Utility connection and specification check
  • Safety device inspection and documentation
  • Calibration status of all instruments
  • Drawing and documentation review
  • SOPs and training record verification
Operational Qualification
OQ — Verify It Works Right

Demonstrates the equipment operates within specified ranges across its full operating envelope. Each critical process parameter is challenged at its limits.

  • Operating range testing at low, mid, and high setpoints
  • Alarm and interlock functional testing
  • Control system response verification
  • Worst-case condition testing
  • Calibration verification of process instruments
  • Full data capture and deviation management
Performance Qualification
PQ — Prove It Does the Job

Confirms the equipment consistently performs within specifications under real process conditions using your actual materials or representative product.

  • Process simulation with representative product
  • Reproducibility across multiple runs
  • Critical quality attribute measurement
  • Statistical analysis of results
  • Operator procedure validation
  • Regulatory-ready summary report
FDA Submission Ready Packages Available
Additional Validation Services

Beyond IQ/OQ/PQ

Specialized validation services for the full range of pharmaceutical manufacturing equipment and utilities.

Steam

Autoclave Validation

Steam sterilizer validation including temperature distribution, penetration studies, and biological indicator programs. Cycle development and qualification.

Thermal

Oven Qualification

Temperature uniformity studies for ovens, dryers, and dry heat sterilizers. Hot spot and cold spot identification with full mapping reports.

Clean

Clean Room Qualification

ISO classification testing, pressure differential verification, air change rate measurement, and HEPA filter integrity testing.

Water

Water System Validation

Purified water and WFI system qualification. Conductivity, TOC, microbial monitoring, and distribution loop validation per USP standards.

HVAC

HVAC Qualification

Air handling unit qualification including temperature, humidity, air volume, and filter performance verification for GMP manufacturing areas.

Cleaning

Cleaning Validation Support

Calibration of analytical instruments and process equipment used in cleaning validation programs. Swab and rinse sample support.

Ready to Get Started?

Contact us for a free quote or to schedule on-site service.

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HoursMon–Fri: 7:00 AM – 6:00 PM ET