The document discusses the layout and design requirements for a pharmaceutical manufacturing facility. It outlines three main types of layouts - circular flow, parallel flow, and crossover traffic. It emphasizes the importance of proper airflow, temperature control, humidity control, and negative pressure differentials between areas to prevent cross-contamination. It also lists key equipment needed for mixing, granulating, drying, compression, coating, and packaging operations.

1. By , Mr. Nitin M. Kadam [email_address]

2. BUILDING & FACILITIES Designed according to cGMP practices which ensures ; Prevention of cross contamination Proper air handling systems. Proper cleaning & sanitary facilities. Proper Lighting Proper Plumbing Proper washing .etc.

3. LAYOUT It is the organized properly planned Interdepartment and Intradepartment arrangements. Proper layout Increases productivity Helps in proper utilization of MAN MATERIAL MONEY MACHINES

4. TYPES OF LAYOUT Three Types of layout With 1) Circular Flow 2) Parallel Flow 3) Crossover Traffic

5. layout with Central warehouse (crossover traffic)

6. Circular flow

7. Parallel flow

8. Environmental Requirements Proper maintenance is required for Product Protection Employee Comfort Controlled Process Parameters

9. Name of area Pressure maintained In pascals Warehouse 10 Weighing area 20 Tableting area 15 Central corridor 30

10. Some Important Aspects low Humidity for Effervescent tablets & moisture sensitive drugs. Pressure within areas like mixing & tableting area should remain on negative side than central corridor All areas should be free from dust & floating particles , if possible air conditioned. In coating section suitable exhaust systems There should be properly organized & working air handling system to supply purified air.

11. Temp control & Air control should be such that there should be comfortable working environment. And no impact on characteristics of in-process materials such as granulations, raw materials. All areas should be properly ventilated.

12. LIST OF EQUIPMENTS MIXING, GRANULATION & DRYING AREA Powder mixer Mass mixer / Planetary mixer / Rapid mixer granulator Sifter Granulators (High shear granulator, chilsonator, ) Tray dryer / FBD Weighing Machines

13. COMPRESSION AREA Tablet compression machine Single punch / Multipunch / Rotary Punch & Die storage cabinet Tablet deduster Tablet inspection unit or belt. Dissolution testing apparatus IPQC instruments

14. COATING AREA Jacketed kettle (steam, gas, Electrically heated) Coating pans Polishing pans Exhaust system Air conditioning & Dehumidification equipment Weighing balance.

15. PACKAGING AREA Strip or Blister packaging Machine. Tablet counter Leak tester Air conditioning & Dehumidification equipment

16. [email_address]