FASILITAS DAN BANGUNAN (FARMASI INDUSTRI)

Summary

This video script outlines the essential design and maintenance principles for pharmaceutical manufacturing facilities in Indonesia. It emphasizes the importance of clean, organized spaces to prevent contamination and ensure drug quality, focusing on key elements such as building layout, equipment, storage, and air control. The script also highlights the significance of protecting the facility from environmental factors, including pollution, and stresses proper segregation for different types of drug production, particularly for high-potency substances and controlled materials. Furthermore, it provides guidelines for ensuring the integrity and safety of the production process through rigorous quality control and safety measures.

Takeaways

• 😀 Adequate design and construction of buildings and facilities are essential for drug manufacturing to minimize risks and ensure quality.
• 😀 The layout of rooms should minimize cross-contamination risks and facilitate effective cleaning and sanitation.
• 😀 Buildings must be designed and maintained to avoid environmental pollution and the entry of rodents or other animals.
• 😀 Maintenance of buildings and facilities should not compromise the quality of drugs; it should be done carefully and regularly.
• 😀 Proper electrical power, lighting, temperature, humidity, and ventilation are crucial for preventing adverse impacts on drug production.
• 😀 Areas designated for specific production activities should avoid being used as public traffic routes to reduce contamination risks.
• 😀 High-risk drugs, such as penicillin, cytotoxic drugs, and hormones, should be produced in separate buildings with additional precautions.
• 😀 Storage areas should be adequate to store materials and products neatly, with controlled environments where necessary, such as for humidity-sensitive materials.
• 😀 Production areas must have smooth, cleanable walls, floors, and ceilings to facilitate effective cleaning and prevent contamination.
• 😀 Quality control laboratories and production areas must be separated, with each having specific environmental and safety controls to prevent contamination and interference.

Q & A

What is the importance of building and facility design in drug manufacturing?

The design and layout of buildings and facilities are critical to minimize cross-contamination, facilitate effective cleaning, and ensure proper maintenance, which are essential for maintaining the quality of drugs and preventing contamination.

How should drug manufacturing buildings be located to avoid environmental contamination?

Buildings should be located in areas that minimize the risk of pollution from the surrounding environment, such as air, soil, water pollution, and nearby industrial activities. If the location is not suitable, preventive measures should be taken.

What measures should be taken to prevent contamination in drug manufacturing facilities?

Measures include appropriate construction materials, ensuring rooms are smooth and free of cracks, implementing effective sanitation procedures, and ensuring equipment and surfaces can be easily cleaned and disinfected.

What precautions are necessary for handling high-risk drug products like penicillin or cytotoxic drugs?

These drugs should be produced in separate buildings, with specific precautions taken to prevent cross-contamination. In cases where they are produced in the same facility, validation and careful precautions are required.

Why is it important to prevent production areas from becoming public traffic routes?

Preventing unauthorized personnel from entering production, storage, and quality control areas is crucial to avoid contamination, mix-ups, and to maintain the integrity of the manufacturing process.

What design considerations should be made for production area floors and walls?

Floors should be waterproof, smooth, and easy to clean, with curved corners between walls and floors. Walls and ceilings should be designed to prevent the accumulation of particulates and allow for effective cleaning and disinfection.

How should air control systems be designed in drug manufacturing areas?

Air control systems should be designed to effectively ventilate the production areas using filters that prevent cross-contamination. Temperature and humidity controls should also be in place to meet the needs of the products being processed.

What is the importance of cleaning and maintenance in drug manufacturing facilities?

Cleaning and maintenance are vital to ensure that production areas remain hygienic and free from contaminants. Regular maintenance and cleaning schedules should be followed to prevent any adverse impacts on product quality.

How should storage areas for materials and products be designed?

Storage areas should be organized to store various materials and products in an orderly and safe manner. These areas should be clean, dry, well-lit, and maintained within the specified temperature limits to ensure the quality of the materials and products.

What is the role of quarantine areas in drug manufacturing facilities?

Quarantine areas are used to store materials and products that are awaiting inspection or approval. These areas should be clearly marked and access should be restricted to authorized personnel to prevent unauthorized handling of materials or products.