How to safely conduct step in drug stability testing?

1、 What is a walk-in drug stability laboratory?

The walk-in drug stability laboratory is a scientific method that creates a long-term stable temperature, humidity, and lighting environment for evaluating the failure of bulk drugs. It is suitable for pharmaceutical companies to conduct accelerated testing, long-term testing, and high humidity testing of drugs and new drugs. It is the preferred solution for pharmaceutical companies to conduct large-scale drug storage and stability testing, making it convenient for long-term moisture resistance cycling testing of bulk drugs.

2、 What are the requirements for a general walk-in drug stability laboratory?

High humidity test: Temperature is 25 ℃± 2 ℃, humidity is 90% R.H ± 5%, or 75% ± 5%.

Accelerated test: 40 ℃± 2 ℃, 75% ± 5% or 30 ℃± 2 ℃, 65% ± 5%; For pharmaceutical preparations packaged in semi permeable containers, such as plastic bagged solutions, plastic bottled eye drops, and nasal drops, the dosage should be 40 ℃± 2 ℃, 20% ± 5%, or 25 ℃± 2 ℃, 20% ± 5%.

Long term experiment: 25 ℃± 2 ℃, 60% ± 5%. For drug formulations packaged in semi permeable containers, such as plastic bagged solutions, plastic bottled eye drops, and nasal drops, 25 ℃± 2 ℃, 40% ± 5% should be used.

Medium condition additional test: 30 ℃± 2 ℃, 40% ± 5%.

High temperature test: 40 ℃, 60 ℃.

3、 How to safely use a walk-in drug stability laboratory?

1. Preparation before use

Environmental preparation:

① Temperature: 5-35 ℃;

② Relative humidity: ≤ 85% R.H;

③ Atmospheric pressure: 86-106Kpa;

④ There is no strong vibration or electromagnetic field around;

⑤ There is no high concentration of dust or corrosive substances around, no direct sunlight or direct radiation from other heat sources;

⑥ The equipment should be placed horizontally in a well ventilated laboratory, with a 1-meter space around it for maintenance and air flow ventilation.

2. Laboratory preparation:

① Install sample racks at appropriate intervals, place test samples reasonably, allow air to circulate inside the box, and clean up other debris inside the box to ensure cleanliness and tidiness.

② Add water to the water tank until it reaches the upper limit, and then close the water tank door.

③ Connect the device power to a grounded power outlet (note: connecting to an ungrounded power outlet may cause personal injury accidents such as electric shock).

④ Set the overtemperature protection temperature value (with the knob located above the back of the box), usually set to around 10-20 ℃ higher than the test temperature.

4、 Why choose Chuangce Technology's walk-in drug stability testing box?

1. Product safety:

① Imported humidity sensor, with high accuracy and small annual drift, can fully ensure the high reliability of humidity measurement values.

② Set up a gate access control system to prevent unauthorized personnel from accidentally opening the door.

③ The heating system uses nickel chromium electric heating wire to heat the air, and heats the box and test products inside through thermal conduction, without directly radiating the test samples.

2. System security

① Independent over temperature protection system, safe and reliable.

② The intelligent temperature and humidity touch screen control instrument is adopted, which can directly set and display temperature and humidity, accumulate equipment running time, and can correct measurement errors online. The controller is equipped with a control switch unit, which can control the on/off function of the working unit separately, and has fault prompt screens such as equipment overheating, water outage, and water shortage. The function is powerful and convenient for operating and monitoring the entire system.

③ Temperature and humidity deviation SMS alarm function, realizing remote management of equipment status