Planning of Pharmaceutical & Biological Clean Production Workshop

To build a fully compliant pharmaceutical and biological clean workshop, the design must comply with relevant authoritative standards and acceptance specifications. Comprehensive planning shall be carried out covering compliance requirements, functional zoning and environmental control.

1. Compliance Foundation & Core Standards

(1)All design and construction shall strictly follow GMP for pharmaceuticals, ISO 14644 series standards and the design code for clean rooms in pharmaceutical industry.

(2 )Four cleanliness grades (Grade A/B/C/D) are classified based on production contamination risks.

(3)Temperature: 18–26℃; Relative humidity: 45%–65%; Pressure differential between adjacent clean zones: ≥5 Pa; Pressure differential between clean areas and outdoor atmosphere: ≥10 Pa.

2. Clear Functional Zoning

(1)In accordance with the production process flow, the workshop is divided into functional areas including raw material storage, preparation, filling and packaging. Separate routes for personnel and materials are designed to avoid cross-contamination and reduce pollution risks.

(2)Critical areas such as filling rooms and aseptic assembly lines shall be equipped with independent enclosed spaces, supported by buffer rooms and air showers. A stepwise pressure differential gradient shall be formed between areas of different cleanliness grades to guarantee unidirectional air flow from higher clean zones to lower clean zones.

(3) Independent dedicated passages are arranged for staff, raw materials and waste respectively with zero cross-over. Personnel shall pass through gowning, disinfection and air shower rooms before entering clean zones.

3. Supporting HVAC System & Decoration Works

(1)A three-stage filtration system (primary filter + medium efficiency filter + HEPA high efficiency filter) is adopted. Negative pressure design is applied to high-risk biological operation areas to prevent leakage of pollutants.

(2) Wall panels, flooring and ceiling shall adopt seamless, corrosion-resistant and easy-to-clean materials such as cleanroom color steel plates and epoxy resin flooring. All pipeline wall penetrations shall be fully sealed.

(3) Equip constant temperature & humidity air-conditioning system, explosion-proof dust-proof LED lighting, emergency eyewash stations, real-time pressure differential monitoring & alarming devices.

(4) Supply and return air ducts shall be reasonably arranged to form uniform and stable indoor airflow, eliminate air vortexes and dead corners, and prevent accumulation and spread of contaminants.

4. Acceptance Inspection & Operation & Maintenance Control

(1) Complete full-set verification tests in line with standards, including air cleanliness classification, temperature & humidity, airflow pattern, pressure differential gradient and operating efficiency of purification equipment.

(2) Establish complete GMP training and assessment system for all staff; formulate standardized protocols for clean transfer of materials and equipment; conduct regular environmental monitoring and retain complete traceability records.

5. Personnel & Material Control Management

(1 )All operators accessing the clean workshop must receive systematic GMP training to master cleanroom operating standards and personal hygiene requirements. Gowning rooms and air showers shall be deployed with strict access procedures to fully decontaminate personnel before entering clean zones and minimize contamination sources.

(2) Formulate standardized management regulations for raw materials and production equipment to ensure all items are free from contamination during storage, transportation and on-site usage.