HVAC Validation, Autoclave Validation, Hospital Validation, Biosafety Cabinet Validation, Thermal Mapping, Stability Cabinet Mapping, Tunnel Validation, LAF Validation, Warehouse Mapping, HEPA Filter Integrity Test, Particle Counting.

ICCE is distributor of ATI Technologies.
ICCE is distributor of CAT GmbH.

I.C.C.E. Istanbul serves for pharmaceutical, medical device, electronic, food industries and hospitals with authorized, competent and experienced team and equipments having latest technologies.

I.C.C.E. Istanbul has been established by Pharmacist Dilek Sunar in 1998 as a representative of I.C.C.E. Belgium. ICCE Belgium was bought by SNC – Lavaline in 2002. I.C.C.E. Istanbul was entirely owned by Dilek Sunar in 2003. SNC - Lavaline Pharma and I.C.C.E. Istanbul had worked together until I.C.C.E. Istanbul’s accreditation. ICCE has been working with 95% of the Turkish pharmaceutical industry for 24 years. With its experienced staff, it has been giving training to the Ministry of Health and the Ministry of Agriculture for years. With a team of 11 people, it serves its customers with its strong equipment park (Kaye Validator Irtd LTR HTR 3 sets-ATİ Photometer-Generator 5 sets-Cat 2 sets-Climet 7 sets corintech datalogger 160 units TSI Accubalance 3 units vsvs.

I.C.C.E. Istanbul has been accredited for HVAC and LAF Validations up to “ISO 17020” Inspection Standard by TURKAK on 27th July 2007 with AB-0053-M accreditation number. With this accreditation, our validation reports have gained recognition and validity all over the world and our company has been approved as a third party impartial and independent “Type A” inspection body.

SERVICES
1. HVAC Heating, Ventilation and Air Conditioning System Validation in Accreditation Scope
• HEPA Filter Integrity/Leakage Test
• Airflow Volume/Velocity Test
• Air Pressure Difference Test
• Temperature and Humidity Test
• Airflow Direction/Characterization/ Visualization Test
• Decontamination – Recovery Test
• Airborne Particle Count and Clean Room Classification

2. LAF Laminar Airflow Validation in Accreditation Scope
• HEPA Filter Integrity/Leakage Test
• Airflow Volume/Velocity Test
• Airborne Particle Count
• Airflow Direction/Characterization/ Visualization Test

3. Oven, Incubator, Cold Room, Refrigerator, Stability Cabinet Heat Distribution Mapping Test

4. Sterilizator (Autoclave, Dry Heat Oven, Tunnel) Validation

5. Water Systems Validation (WPU/WFI)

6. Hot/Cold Closed Water Loop Validation

7. Lyofilizator Validation

8. Audits
• EU/FDA Preparation Audits
• Supplier Audits (Including Computer and Software System Suppliers)
• Specific Process/Product Audits
• Potential Problem Audits

9. Training (GMP, GLP, Validation, Risk Management, Audit, FDA and Health Ministry Requirements, Clean Room Design, Quality etc.)

Clean Room Design and Validation
Clean Room
What is Clean Room?
Clean Room Areas
Clean Room Design Requirements
• Design and Project
• Construction Materials
• Equipments
• HVAC System
• Hygiene Controls
• Circulation
• Personnel and Training
• Documentation
• Controls
HVAC System
AHU Types
HVAC System Components
Filters
Clean Room Classifications
Clean Room Standards and Guidelines
ISO 14644-1, 2, 3, 4
Eudralex Annex-1
FDA Guideline On Sterile Drug Products Produced By Aseptic Processing
IEST-RP-CC006 & 34
HVAC Validation
User Requirement Specifications (URS)
Validation Master Plan (VMP)
Functional Specifications (FS)
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
• Physical
• Microbiological
Validation Documentation
Master Plan
Protocol
Records
Report

SALES
AIR TECHNIQUES INTERNATIONAL (ATI)
I.C.C.E. Istanbul is Turkey Sales Distributor of ATI since 1998.

ATI photometer and aerosol generators that are in all literatures, especially in HEPA filter integrity tests are available for sale in different models.

Photometer calibrations, which used to be made abroad, have been made by I.C.C.E. Istanbul once or twice in a year since 2005.

You can visit www.atitest.com website for more information about ATI.

CAT Clean Air Technology GmbH

Cat Fog generator

Cleanrooms are dynamic systems. People and goods are constantly in motion. Further installations, production lines and machines are from time to time adapted to the fabrication of different products. According to the relevant standard ISO 14644 part 3Annex B7 the operators of cleanrooms are obliged to periodically give evidence of the actual airflow situation by an airflow mapping based on high purity water fog generators of CAT’s VP series. VP series systems do provide a high volume, density and purity of fog based on nothing else than pure water (deionised water or water for injection). The water fog is generated by atomizing deionised water into micro water droplet fog. The generated fog is ultra-pure leaving no traceable particles after its evaporation

PARTNERSHIP
ACADEMIA LIFE SCIENCES CENTRE (ALSC)
I.C.C.E. Istanbul’s training services are incorporated with Academia Life Sciences Centre (ALSC).
ALSC is founded in May 2006 with collaboration of our business partners I.C.C.E. Istanbul. Our seminar experience goes back to 1998 with I.C.C.E. Istanbul.

Academia provides trainings mainly on the following areas:
• GXP
• QA
• Validation
• Risk Management etc.

You can visit www.academialsc.com website for more information about ALSC.