Klasifikasi Ruangan di Industri Farmasi

Summary

In this video, Garnis Viola Afri Zatira, a student from Riau College of Pharmaceutical Sciences, explains the classification of rooms in the pharmaceutical industry. She introduces the importance of maintaining high-quality drug production by following strict guidelines like CPOb to ensure safety and effectiveness. Zatira elaborates on the various room classes (A, B, C, D) based on cleanliness, air quality, and risk levels in drug manufacturing processes, such as aseptic filling, sterile drug production, and solution making. The video offers valuable insights into pharmaceutical industry standards and their impact on drug quality.

Takeaways

• 😀 The pharmaceutical industry involves the large-scale manufacturing of drugs or drug ingredients, requiring official registration and permits.
• 😀 The quality of drug products is influenced by many factors, including raw materials, packaging materials, and equipment used in the manufacturing process.
• 😀 To ensure effective and safe drugs, a guideline for pharmaceutical production, known as CPOT (Good Manufacturing Practice), is necessary.
• 😀 A pharmaceutical production room must meet certain standards, such as waterproof surfaces, no joints or curved wall edges, and proper air duct installation.
• 😀 Key parameters for classifying pharmaceutical rooms include air particle count, microbe levels, air changes, airspeed, pressure differences, temperature, and humidity.
• 😀 The classification of pharmaceutical rooms is based on cleanliness and the risk of contamination, with different cleanliness classes for various production areas.
• 😀 Class A rooms are for high-risk activities, such as aseptic filling, requiring laminar airflow with a uniform airspeed between 0.36 to 0.54 m/s.
• 😀 Class B rooms support aseptic product manufacturing and filling, with a background air exchange rate of at least 20 times per hour.
• 😀 Class C rooms are clean areas for lower-risk manufacturing processes, such as making solutions, with a similar air exchange rate of 20 times per hour.
• 😀 Class D rooms are for lower-risk manufacturing activities, such as final sterilization of sterile drugs, also requiring a minimum of 20 air exchanges per hour.
• 😀 The 2018 CPOT guidelines removed Class E, which existed in the 2012 version, and adjusted cleanliness parameters for different classes.

Q & A

What is the main purpose of the pharmaceutical industry classification system for rooms?

The classification system ensures that rooms in pharmaceutical production environments meet specific cleanliness and safety standards necessary for producing high-quality, effective, and safe drugs.

What factors influence the quality of drug products in the pharmaceutical industry?

Factors that influence drug quality include raw materials, packaging materials, equipment, and the manufacturing process. Each of these elements must be carefully controlled to ensure drug safety and effectiveness.

What does 'CPoB' stand for and why is it important in pharmaceutical manufacturing?

CPoB stands for 'Cara Pembuatan Obat yang Baik', which translates to Good Manufacturing Practices (GMP). It provides guidelines for the pharmaceutical industry to ensure the safe and effective production of drugs.

What are the key parameters used to determine the cleanliness class of a pharmaceutical room?

The key parameters include the number of particles in the air, the number of microbes in the air, the number of air changes, air flow speed, the pressure difference between rooms, temperature, and humidity.

Why was Class E removed from the pharmaceutical industry classification in the 2018 CPoB?

Class E was removed in the 2018 CPoB update as it was found to be essentially the same as Class D in terms of particle parameters, thus making it redundant.

What is the primary function of Class A in the pharmaceutical industry?

Class A is a high-risk zone, used for critical activities such as filling sterile products (e.g., ampoule filling, sterile eye ointment). It requires laminar airflow to maintain sterility and safety.

How is air circulation controlled in Class B rooms?

In Class B rooms, the air exchange occurs at a minimum rate of 20 times per hour, and the air flow is turbulent. These rooms support aseptic product manufacturing and filling, and also serve as a background for Class A zones.

What types of activities are performed in a Class C room?

Class C rooms are used for manufacturing processes that have a lower risk, such as making solutions or preparing products for final sterilization. Aseptic filling is done in Class A, with a Class B background.

What is the significance of air exchange in Class D rooms?

In Class D rooms, air exchange is similarly controlled with a minimum of 20 times per hour, and these rooms are used for lower-risk activities, like the final sterilization of drugs.

Why is laminar airflow important in pharmaceutical rooms, particularly in Class A?

Laminar airflow is important in Class A rooms because it ensures a uniform flow of air that helps maintain a sterile environment, preventing contamination during critical processes like filling sterile products.