Service Overview
In pharmaceutical manufacturing, water systems and cleanroom environments represent the most critical quality control pillars. Purified Water (PW), Water for Injection (WFI), Pure Steam, and controlled processing environments must undergo systematic sampling and testing to guarantee microbiological purity, chemical compliance, and zero pyrogenic contamination.
QEEMA Egypt provides end-to-end Pharma Sampling and Analysis Services. Utilizing calibrated, state-of-the-art sampling equipment, sterile protocols, and validated analytical methodologies, our technical team supports pharmaceutical, biopharmaceutical, and medical device plants with routine sampling, method validation, trend analysis, and emergency Out-Of-Specification (OOS) investigations compliant with EDA, USP, Ph. Eur., and WHO guidelines.
Core Scope & Technical Deliverables
Purified Water (PW) & WFI Testing
Comprehensive physical, chemical, and microbiological testing of PW loops, WFI generation units, storage tanks, and point-of-use (POU) valves.
- TOC (Total Organic Carbon) & Conductivity
- Bioburden & Bacterial Endotoxin (LAL) testing
- Nitrates, Heavy Metals & pH analysis
Cleanroom Environmental Monitoring (EM)
Routine and qualification sampling of Grade A, B, C, and D cleanrooms for viable and non-viable particulate contamination.
- Active air sampling (volumetric samplers)
- Passive air sampling (settle plates)
- Surface swabs & contact plates (rodac)
- Personnel glove & gowning monitoring
Pure Steam & Process Gas Sampling
Specialized sampling and testing of Pure Steam quality, Compressed Air, Nitrogen, and process gases entering sterile filling zones.
- Clean steam dryness, superheat & non-condensable gas
- Compressed air oil mist & dew point measurement
- Microbiological air particulate testing
Trend Analysis & OOS Investigations
Establishing alert/action limits, compiling statistical environmental monitoring trends, and conducting root-cause investigations for OOS/OOT events.
- Microbiological alert & action limit setup
- EM & Water statistical trend reports
- Root cause analysis (RCA) for contamination
Implementation Methodology
Sampling Protocol & Schedule Setup
Establishing risk-based sampling plans, sampling point maps (POU & EM locations), and validated sampling procedures (SOPs).
Sterile On-Site Sampling Execution
Deploying qualified QC technicians equipped with sterile sampling vessels, calibrated air samplers, and temperature-controlled transport.
Laboratory Chemical & Microbiological Testing
Executing TOC, conductivity, endotoxin LAL gel-clot, membrane filtration bioburden, and microbial identification per USP/Ph. Eur.
Data Evaluation & Trend Reporting
Compiling analytical certificates of analysis (CoA), evaluating data against alert/action thresholds, and issuing trend reports for QA review.
Target Sectors & Applications
Our specialized consulting services cater to: