Stability Pharmaceutical Chambers

Description

Stability pharmaceutical chambers are designed to maintain specific temperature, humidity, and lighting conditions, which can simulate various environmental conditions that the drug may be exposed to during storage and transportation. The purpose of drug stability testing is to ensure that the drug retains its quality, safety, and efficacy over its shelf life, and that it meets the regulatory requirements for approval.

Specification

Safety protection:

·Independent temperature limiter: An independent shutdown and alarm for thermal protection purpose during the test.

·Refrigeration system: Over-heat, over-current and over-pressure protection of compressor.

·Test chamber: Over-temperature protection, overheat of fan and motor, phase failure/reverse, timing of the entire equipment.

·Others: Leakage and outage protection, overload fusing protection, audio signal alarm, power leakage protection, and overload

Protection.

Temperature and humidity curve:

■Pharmacopoeia Drug Stability Guidelines of Raw Drugs and preparations and the

temperature and humidity test conditions required in the ICH guidelines:

The ambient temperature for the following tests shall be between 15~25℃

√Accelerated test: 40℃±2℃ / 75%±5%RH, or 30℃±2℃ / 65%±5%RH

√High humidity test: 25℃ / 90%±5%RH, or 25℃ / 75%±5%RH

√Long-term test: 25℃±2℃ / 60%±5%RH, or 30℃±2℃ / 65%±5%RH

√For accelerated testing of drug preparations packaged in semi-permeable

containers, such as infusion bags prepared by LDB, plastic ampoules, and ocular

preparation containers etc,tests shall be performed at temperature 40℃±2℃/25%±5%RH

√For long-term testing of pharmaceutical preparations packaged in semi

permeable containers, it should be at a temperature of 25℃±2℃/40%±5%RH or 30℃±2℃/35%±5%RH

Feature of stability pharmaceutical chambers

Stability pharmaceutical chambers comes in various designs and models, but generally, they have the following features:

1.Temperature control: Stability pharmaceutical chambers maintains precise temperature control, the temperature range can be as low as -20°C to as high as 70°C.

2.Humidity control: The humidity level inside the stability pharmaceutical chambers can be adjusted to simulate different humidity. This is particularly important for moisture sensitive drugs, such as certain types of solid dosage forms and biologics.

•Programmable touch screen controller

. 100 programs, 1000 segments 999 steps, 99 hours 59 minutes for each segment.

. P.I.D automatic calculation function.

. RS485communicationinterface/ a built-in printer available, for data storage and playbackof history curve.

. Data recording and fault diagnosis display, once a fault occurs, the cause of faultwill be dynamically displayed on the controller.

3.Lighting control: Some drugs are light sensitive, and may degrade if exposed to certain wavelengths of light. Therefore, Climatest Symor®stability pharmaceutical chambers has lighting controls, like UV light, to determine the effect of light on the drug product.

4.Airflow control: Stability pharmaceutical chambers has air circulation systems to maintain consistent and uniform temperature and humidity throughout the chamber.

5.Data logging and monitoring: Stability pharmaceutical chambers is equipped with sensors and data logging systems that monitor and record temperature, humidity, and other environmental parameters, which can be used to generate reports and validate the stability of the product.

Overall, stability pharmaceutical chambers aims to ensure that the drugs are stored and tested under controlled environmental conditions that simulate real-world conditions, and to provide accurate and reliable stability data for regulatory approval.

Testing area:

The testing area of a stability pharmaceutical chambers is made of stainless steel SUS304, and is designed to simulate constant temperature, humidity, and lighting conditions. The chamber is equipped with high-precision temperature & humidity sensors to monitor and maintain these climatic conditions.

There are racks or shelves to hold the drug samples, these shelves are height adjustable, and the samples are usually placed in tightly sealed glass vials or containers to prevent contamination.

Benifits from stability pharmaceutical chambers

So what benefits can Climatest Symor®pharmaceutical stability test chamber bring to you?

. Quality control: Pharmaceutical stability test chamberhelpspharmaceutical companies test quality and safety of their products by providing data on how drugs will perform over time, this data help manufacturers make informed decisions about the shelf life, storage, and packaging of their products.

. Regulatory compliance: Stability pharmaceutical chambers isrequired by regulatory agencies, such as the FDA, to test the stability of drugs and other healthcare products.

. Reduce costs: By testing the drug stability before releasing to the market, pharmaceutical companies can reduce the risk of product failures and recalls. This can result in significant cost savings.

. Improved product development: By testing thedrugstability under various environmental conditions, manufacturers can identify potential problems early in the development process.

Overall, stability pharmaceutical chambersplaysa critical role in ensuring the safety, efficacy, and quality of drugs and other healthcare products.

The function of stability pharmaceutical chambers

Stability pharmaceutical chambers is designed to meet strict regulatory requirements and industry standards, such as those set by the International Conference on Harmonisation (ICH Guideline). The chambers can be used for a variety of purposes, including:

*Long-term storage stability testing: This type of testing is used to determine the stability of a drug over an extended period of time, typically several years.

* Shelf-life testing: Stability chambers in pharmaceutical are used to determine the shelf life of a drug, which is the amount of time a product can be stored under specific conditions without losing its potency, efficacy, or quality.

*Accelerated stability testing: This type of testing is used to evaluate the stability of a drug under extreme conditions, such as high temperatures and humidity, in a short amount of time.

Based on the results of stability testing, the manufacturer can determine the shelf life of the product and make any necessary adjustments to the formulation or packaging to ensure the product remains stable over time. This information is critical to regulatory agencies, who use it to determine the appropriate storage and handling requirements for the drug.

Overall, stability pharmaceutical chambers plays a essential role in ensuring the safety and efficacy of drugs, and they are an essential tool for the pharmaceutical industry.

Influencing factor test in a drug stability chamber

Stability pharmaceutical chambers is often used in pharmaceutical research and development, quality control, and manufacturing facilities, as well as in regulatory agencies that oversee drug approval and safety.

Influencing factor test (stress testing, also known as intensive test) aimsto explore the inherent stability of the drug, understand the factors that affect its stability, and possible degradation pathways and degradation. Provide scientific basis for preparation production process, packaging, storage conditions and establishment of degradation product analysis methods.

Below is a test case to show the influencing factor teston pharmaceutical raw materials:

①High temperature test:

Temperature: @60°C

Time:10 days

Take out samples on the 5^thday and testthem according to the key stability inspection items.If the samples contentis lower than the specified limit, carry out the abovetest at 40°C; if no significant change at 60°C, no need carry out the test at 40°C.

②High humidity test:

Temperature:@25°C

Relative Humidity: 90%±5%

Time:10 days

Take out samples on the 5^thday and 10^thday, and testthemaccording to the key stability inspection items. meanwhile, accurately weigh thesamplesweight before and after the test,to investigate the moisture absorption and deliquescence performance.

If the weight gain is >5%,the above test shall be carried out in the same method under relative humidity of 75%±5%;

If the weight gain is <5% and other conditions meet the requirements, 75%±5% test shall not be carried out.

③Intense light irradiation test:

Illumination: 4500LX±500LX

Time: 10 days

Take out samples on the 5^thday and 10^thday, and testthemaccording to the key stability inspection items, pls pay attention to the appearance changes of the samples.

Certificates of stability pharmaceutical chambers

Certificates of stability pharmaceutical chambers is official documents issued by the manufacturers or accredited third-party organizations, it verifies the performance and compliance of the chamber with relevant regulations and standards. Climatest Symor®isISO9001:2015 certified, all stability test chambers are CE approved.

On-site installation pictures

Installing stability pharmaceutical chamberss require careful planning and attention to detail to ensure that it is properly installed and functions as intended, following pictures are taken at end user’s site.