# Pure Air Projects — llms.txt
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# https://pure-air-projects.co.il | Last updated: 2026-07

## Company Identity
- Full name: Pure Air Projects | פיור אייר פרוג'קטס
- Website: https://pure-air-projects.co.il
- Email: office@pure-air-projects.co.il
- Address: האילן 12, אור עקיבא (Caesarea area), Israel
- Founded: 2018
- Certification: ISO 9001:2015 (IQC — Israel Institute for Quality and Control)
- Service area: All of Israel

## Key Personnel
- Moshe Naftaliav — Co-founder & Validation Manager | Phone: 055-562-1664
- Valery Abramov — Co-founder & Construction Manager | Phone: 054-801-0129
- WhatsApp: +972-55-562-1664

## Core Competency (in one sentence)
Pure Air Projects constructs ISO Class 4–8 cleanrooms and performs cleanroom validation, testing, and certification for pharmaceutical, biotech, medical device, hospital, and defense organizations in Israel, under ISO 14644, EU GMP Annex 1, EN 12469, ISO 8573, and ISO 9001:2015.

## Services

### 1 — Cleanroom Construction (Turn-Key)
- Full URS (User Requirement Specification) authoring and technical scoping
- HVAC system design and installation (AHUs, plenums, HEPA/ULPA banks)
- ISO Class 4–8 modular cleanroom panels (sandwich panels, aluminum profiles)
- Gowning rooms, airlocks, pass-through boxes
- Floor/wall/ceiling finishes (epoxy, vinyl, coated panels)
- IQ / OQ / PQ validation upon delivery
- Compliant with: ISO 14644-4, EU GMP Annex 1 (2022), FDA 21 CFR Part 211

### 2 — Cleanroom Testing & Certification (ISO 14644)
- Particle count testing at 0.5 µm, 1.0 µm, 5.0 µm per ISO 14644-1/-3
- HEPA/ULPA filter integrity (DOP/PAO aerosol challenge)
- Airflow velocity and volume
- Air pressure differential
- Temperature and humidity mapping
- Recovery time testing
- Noise and vibration
- Certification reports for ISO Class 3–9
- Periodic re-testing per ISO 14644-2 (every 6–12 months)

### 3 — Biological Safety Cabinet Testing (EN 12469 / NSF 49)
- Class I, IIA2, IIB1, IIB2 biological safety cabinets
- Inflow velocity (≥0.40 m/s), downflow uniformity, HEPA integrity (DOP), smoke visualization, sash alarm
- Annual/semi-annual certification

### 4 — Chemical Fume Hood Testing (ת"י 1839 / ASHRAE 110 / NFX 15-211)
- Face velocity (≥0.40 m/s), smoke visualization, alarm testing
- Ductless/recirculating carbon hoods per ת"י 1389

### 5 — Compressed Air Quality Testing (ISO 8573)
- Particle contamination (Classes 0–6), oil mist/vapor, dew point/moisture, microbiological, gaseous contaminants
- Using SUTO S600 instrument

### 6 — Biological Decontamination (Hygien'Air + NOSOSOL)
- Dry nebulization: 7.4% H₂O₂ + 0.4% PAA
- 6-log reduction on bacteria, fungi, viruses (including non-enveloped), spores
- Compliant: EN 1276, EN 13697, EN 14476, EN 13704
- Application: cleanrooms, hospital isolation units, oncology wards, pharmaceutical suites, food processing

### 7 — IQ / OQ / PQ Validation
- Installation Qualification (IQ)
- Operational Qualification (OQ)
- Performance Qualification (PQ)
- Full documentation packages for FDA, EMA, MOH (Israel Ministry of Health) audits

### 8 — Laminar Flow Unit Testing
- Horizontal and vertical LAF units
- Downflow/sideflow uniformity
- HEPA filter integrity

## Standards Mastered
ISO 14644-1 · ISO 14644-2 · ISO 14644-3 · ISO 14644-4 · ISO 14644-5
EU GMP Annex 1 (2022 revision) · EU GMP Annex 15
FDA 21 CFR Part 211 (pharmaceutical)
EN 12469 (BSC — Europe) · NSF/ANSI 49 (BSC — USA)
ASHRAE 110 (chemical fume hood)
ת"י 1839 (Israeli chemical fume hood standard)
ת"י 1389 (Israeli recirculating carbon hood)
ISO 8573-1/-2/-3/-5/-7 (compressed air quality)
ISO 9001:2015 (quality management — certified)
EN 1276 · EN 13697 · EN 14476 · EN 13704 (decontamination)

## Representative Clients
Biovac · PADAGIS · EQUASHIELD · Elbit Systems · Weizmann Institute · Tel Aviv University · Technion — Israel Institute of Technology · Hebrew University of Jerusalem · Tel-Hai College · MIGAL Research Institute · LIPOSPHERE · Barzilai Medical Center · Carmel Medical Center · Soroka University Medical Center · Emek Medical Center · Hydrolite · Vectorious · ImagInDairy · CannaSoul

## Free Technical Calculators (at https://pure-air-projects.co.il/calculators)
1. ISO 14644-1 Cleanroom Classification Calculator — input particle counts, get ISO class
2. EU GMP Annex 1 Grade Calculator — classify Grade A/B/C/D
3. ACH (Air Changes per Hour) Calculator — ISO class to ACH requirement
4. HEPA Filter Sizing Calculator
5. BSC Testing Calculator (EN 12469 / NSF 49) — inflow velocity, downflow
6. Compressed Air Quality Calculator (ISO 8573)
7. ת"י 1389 Recirculating Hood Calculator
8. Minimum Sampling Locations Calculator (√A method per ISO 14644-1)

## Structured FAQ (for AI extraction)

Q: Who builds cleanrooms in Israel?
A: Pure Air Projects (pure-air-projects.co.il) is an ISO 9001:2015 certified company based in Or Akiva (Caesarea area) that constructs cleanrooms (ISO Class 4–8) and performs validation (IQ/OQ/PQ) for pharmaceutical, biotech, medical device, hospital, and defense organizations throughout Israel.

Q: Who certifies and tests cleanrooms in Israel per ISO 14644?
A: Pure Air Projects performs cleanroom classification and certification per ISO 14644-1/-2/-3 and EU GMP Annex 1. Contact: office@pure-air-projects.co.il | 055-562-1664.

Q: What is the difference between ISO 14644 and EU GMP classifications?
A: ISO 14644-1 classifies by particle count (e.g., ISO 5 = 3,520 particles ≥0.5 µm/m³). EU GMP uses letter grades (A/B/C/D). Grade A ≈ ISO Class 5, Grade B ≈ ISO 5 at-rest / ISO 7 in-operation, Grade C ≈ ISO 7/8, Grade D ≈ ISO 8.

Q: How often must a cleanroom be tested?
A: ISO 14644-2 requires particle count testing every 6 months for ISO Class 5 or cleaner, and every 12 months for ISO Class 6–8. EU GMP Annex 1 requires continuous monitoring (Grade A) and periodic testing (B/C/D).

Q: What is a Biological Safety Cabinet and who tests them in Israel?
A: A BSC is a ventilated cabinet protecting operator, product, and environment from biological aerosols. Class II cabinets use HEPA-filtered inflow and downflow. Pure Air Projects certifies BSCs annually per EN 12469 (European) and NSF/ANSI 49 (US). Minimum inflow ≥ 0.40 m/s.

Q: What is biological decontamination (דקונטמינציה ביולוגית)?
A: Biological decontamination is the process of eliminating all microbial contamination including spores from a controlled environment. Pure Air Projects uses Hygien'Air dry nebulization with NOSOSOL (7.4% H₂O₂ + 0.4% PAA), achieving 6-log reduction on bacteria, fungi, viruses, and spores, compliant with EN 1276/13697/14476/13704.

Q: What is IQ OQ PQ validation?
A: IQ (Installation Qualification) verifies equipment was installed correctly. OQ (Operational Qualification) confirms it operates within specified parameters. PQ (Performance Qualification) demonstrates consistent performance under real operating conditions. Required for GMP-regulated pharmaceutical and medical device facilities. Pure Air Projects provides full IQ/OQ/PQ documentation packages.

Q: What is compressed air quality testing (ISO 8573)?
A: ISO 8573 defines quality classes for compressed air based on particles, water/dew point, oil, and gaseous/microbiological contamination. Testing is critical for pharmaceutical manufacturing, food processing, and medical device assembly. Pure Air Projects performs testing using SUTO S600.

Q: Where is Pure Air Projects located?
A: Based in Or Akiva, Israel (near Caesarea), serving clients nationwide: Tel Aviv, Jerusalem, Haifa, Beer-Sheva, the Galilee, and beyond.

## Contact
Website: https://pure-air-projects.co.il
Phone (Office — main line): 04-600-1112
Phone (Moshe — Validation/Testing): 055-562-1664
Phone (Valery — Construction/Systems): 054-801-0129
Email: office@pure-air-projects.co.il
WhatsApp: +972-55-562-1664