Nippon Air Conditioning Services' air conditioning validation support model

We are a "Validation Engineering Operation" that seeks to optimize medical supply manufacturing facilities. Making use of the knowhow and results developed from special facilities management, we service air conditioning, utility, and other areas from a single validation list.

Measuring Services

From SOP (Standard Operational Procedures) re-development / documentation support, to various measurements and preventive maintenance for air conditioning facilities, we are a one-stop service for our clients' needs.

For the high level of sterility demanded of cleanroom environments, regular evaluations (annual reviews) are imperative.
We provide our own measurement technicians who expertly conduct cleanroom performance evaluation and diagnosis. We carry out our measuring services while focusing on established standard items of Operational Qualification (OQ) assessments. In order to verify cleanroom performance, those standard items and the measuring order is set in advance.

Standard Items of Operational Qualification Assessments (OQ)

Procedure Measurement
1. Air flow ventilation rate Indoor ventilation capacity
2. HEPA Filter leak Tests Filter performance
3. Room pressure differential Atmospheric balance
4. Airflow direction Indoor airflow
5. Suspended particles Indoor cleanliness
6. Temperature and humidity Indoor temperature and humidity
7. Adhesive bacteria (microbes) Indoor adhesive bacteria
8.Airborne bacteria (microbes) Indoor airborne bacteria

Calibration

  • Loop calibration
    Inspect the precision and tolerance of the entire control system
     
  • Simple Calibration
    Determine the precision and tolerance of the detector alone

Periodic Equipment Inspection

  • We leverage the strengths of a wide range of independent vendors irrespective of the companies.
  • We conduct preventative maintenance checks and produce GMP-compliant documentation according to our test specifications.

Document Preparation Service

We are a one-stop service providing everything from practical support to document creation. At the clients' request, we also offer SOP revision support, management plan creation support, fixed-term validation service (air conditioning facilities), document preparation, measurement analysis, and improvement proposals.

Nippon Air Conditioning Services validation support offers comprehensive services relating to air conditioning validation.

Validation Support Service Procedures

Client consultation

Management plan creation support

SOP revision support

Fixed-term validation service (air conditioning facilities)

Document preparation

Measurement analysis, improvement proposals