Cleanroom Validation
OCCR provides professional cleanroom validation and on-site testing for Indonesia & Southeast Asia. We conduct IQ/OQ/PQ qualification, environmental parameter measurement and validation dossier preparation. Our test data and technical documents support pharmaceutical, medical device, electronics and life science facilities to meet BPOM, GMP and ISO 14644 audit requirements.
Common Cleanroom Compliance Challenges
BPOM Audit Risks
Incomplete validation test records may cause non-conformity during BPOM inspections and delay product registration.
Unqualified Cleanliness
Particle count, pressure difference or humidity out of spec, failing ISO 14644 cleanroom performance requirements.
Missing Validation Dossiers
Lack of standardized IQ/OQ/PQ test documents, hard to provide evidence for GMP audit inspections.
Limited Local Expertise
Many teams lack local Indonesia GMP experience, resulting in delays for on-site testing and validation documentation.
Our Cleanroom Validation & Testing Services
IQ Installation Qualification
Verify all cleanroom systems are installed as per approved drawings and specifications, generate full installation test documentation.
Learn MoreOQ Operational Qualification
Test cleanroom running performance: air change rate, differential pressure, temperature, humidity and particle distribution, issue test reports.
Learn MorePQ Performance Qualification
Continuous monitoring under real production conditions, collect test data to prove stable facility performance for your manufacturing process.
Learn MoreValidation Dossier Preparation
Complete validation test report packages tailored for GMP & BPOM audit, including protocols, raw test data and summary records.
Learn MoreISO 14644 Cleanroom Performance Testing
On-site particle counting and cleanroom performance testing, deliver test data to verify ISO 14644 cleanroom classification.
Learn MoreGMP & BPOM Audit Technical Support
Provide professional technical support during BPOM and GMP inspections, help respond to non-conformities and corrective actions. We do not issue official certification.
Learn MoreOur Cleanroom Validation & Testing Process
Proses Layanan
01 Scope Definition
Confirm cleanroom zone, GMP requirements and BPOM audit target.
02 Protocol Writing
Develop IQ/OQ/PQ test protocols for your facility.
03 On-site Testing
Perform particle, pressure, temperature & humidity measurement.
04 Data Analysis
Review raw test data, identify deviations and propose corrections.
05 Test Dossier Compilation
Compile full validation test package for audit preparation.
06 Audit Technical Support
Assist during BPOM inspection and periodic re-testing.
Why Choose OCCR for Cleanroom Validation & Testing
Local Indonesia GMP Expertise
Our team understands BPOM regulations and local cleanroom audit requirements for pharmaceutical and medical device factories.
One-stop Validation & Testing
We can combine cleanroom construction and validation testing, seamless handover from installation to audit-ready test documentation.
Periodic Re-testing Service
Provide periodic re-qualification testing and document update service to keep your cleanroom data ready for audits year by year.
FAQ About Cleanroom Validation & Testing
Answers to common questions about our FAQ About Cleanroom Validation & Testing services
Request Cleanroom Validation & Testing Quotation
Tell us your cleanroom class and industry, we prepare tailored validation and testing proposal for your GMP & BPOM audit project.