Stability Chambers in Pharmaceutical

Description

Stability chambers in pharmaceutical are an essential part for medication stability testing. They are specialized environmental chambers designed to maintain a constant temperature and humidity level in order to study the stability of drugs and other pharmaceutical products. Pharmaceutical stability testing is a critical part of the drug development process, as it ensures that drugs maintain their potency, purity, and quality throughout their shelf life.

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 cur

■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

● Humanized design

. New fluorine-free design, high efficiency, low energy consumption, and energy-saving.

. Microcomputer controller, stable, accurate and reliable control.

. Testing zone made by 304 stainless steel, with semi-circular corners, easy to clean and easy to operate.

. Unique air duct circulation ensures uniform air distribution inside, a test hole (Diameter 25mm) locates on the left side of the chamber.

● Continuous operation guarantee

. Two imported compressors switchover automatically, to ensure long-term continuous operation during drug stability testing.

. Continuous operation does not require defrosting, avoiding temperature and humidity fluctuations in defrosting process.

● Safety guarantee

. The independent temperature limit alarm system ensures secure operation without accidents.

. Over-temperature alarm, and over-humidity alarm.

. Password lock screen function to avoid misuse by non-experimental personnel.

● Imported humidity sensor

Imported high-precision humidity sensor that can operate at high temperature, to avoid troubles caused by frequent replacement of wet ball gauze.

● Programmable touch screen controller

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

. P.I.D automatic calculation function.

. RS485 communication interface / a built-in printer available, for data storage and playback of history curve.

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

Benifits from stability chambers in pharmaceutical

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

. Quality control: Stability chambers in pharmaceutical help pharmaceutical 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 chambers in pharmaceutical are required 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 the drug stability under various environmental conditions, manufacturers can identify potential problems early in the development process.

Overall, Stability chambers in pharmaceutical is very important to ensure the safety, efficacy, and quality of drugs and other healthcare products.

The function of stability chambers in pharmaceutical

Stability chambers in pharmaceutical are 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 chambers in pharmaceutical play a critical 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 chambers in pharmaceutical are an essential tool to assess the stability and shelf life of drugs and other pharmaceutical products. These chambers simulates controlled temperature, humidity, and lighting conditions.

Influencing factor test (stress testing, also known as intensive test) aims to 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 test on pharmaceutical raw materials:

① High temperature test:

Temperature: @60°C

Time: 10 days

Take out samples on the 5^th day and test them according to the key stability inspection items. If the samples content is lower than the specified limit, carry out the above test at 40°C; if no significant change at 60°C, no need carry out the test at 40°C.

② High humidity test:

Temperature:@25°C

Relative Humidity: 90%±5%

Time: 10 days

Take out samples on the 5^th day and 10^th day, and test them according to the key stability inspection items. meanwhile, accurately weigh the samples weight 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.

③ Intense light irradiation test:

Illumination: 4500LX±500LX

Time: 10 days

Take out samples on the 5^th day and 10^th day, and test them according to the key stability inspection items, pls pay attention to the appearance changes of the samples.

Certificates of stability chambers in pharmaceutical

Certificates of stability chambers in pharmaceutical are 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® is ISO9001:2015 certified, all stability test chambers are CE approved.

On-site installation pictures

Installing stability chambers in pharmaceutical 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.