id you know that even a small fluctuation in the temperature and humidity range inside a climate chamber can cause a serious NC (Non-Conforming) error? The lack of raw data monitoring records is a very common cause today. This reality severely undermines the reliability of the entire sample storage conditions.
We always need to equip our laboratories with modern equipment to maintain sustainable competitiveness. However, many technicians are still unclear about whether their equipment complies with the correct standards. This article will expose the core errors to help you preserve the legal validity of all tests before the VILAS committee.
1. Equipment Resource Management Violations According to New Provisions
1.1. Violations of Verification Regulations
National standards stipulate very strict requirements regarding the equipment management capabilities of testing laboratories. Specifically, in Section 6.4 (Equipment) of the legal document TCVN ISO/IEC 17025:2017, equipment must meet the necessary accuracy standards. We are required to conduct operational capability verification before putting the machine into use.
For climate chambers, this verification means proving that the convection system is functioning properly. You need to provide complete raw data showing that the humidification chamber maintains a stable environment. Conversely, if the verification status label is missing, the equipment will be immediately flagged as non-conforming by the expert assessor.
1.2. Errors in Retrospective Recording of Sample Storage Logs
In addition, the storage of equipment operation history must strictly adhere to the real-time principle. Many technicians often make the major mistake of leaving the machine’s run data blank for several consecutive days. They then proceed to make retrospective entries based on intuition just before a quality inspection.
This behavior is considered a violation of the transparency of digital records under Section 7.5 of the standard. VILAS assessors will compare the operating log with the original data stored on the machine’s circuit board. To ensure legal safety, we need to proactively maintain the following control practices:
Record raw environmental parameters directly at the end of each shift.
Maintain complete records of the manufacturer’s periodic steam system maintenance reports.
Do not erase or modify the original temperature and humidity data in the logbook.
Failure to store complete historical data is a common error that causes climate control cabinets to fail ISO 17025 certification
2. Temperature and Humidity Error Distribution
2.1. Technical Errors in Nine-Point Mapping
To demonstrate the ability to control the environment within the chamber, dynamic testing methods are mandatory. We must clearly distinguish between two core technical concepts: Uniformity and Fluctuation. According to the international standard IEC 60068-3-6, the allowable error range is extremely strict.
Specifically, temperature uniformity must be ≤±0.5°C and humidity must be ≤±3%RH. For fluctuation, the ideal error should not exceed ≤±0.1°C and humidity ≤±2%RH. Currently, the TH-TG-1000 temperature and humidity test chamber from Jeiotech, South Korea, meets these parameters exceptionally well thanks to its intelligent sensor system. If the technician incorrectly positions the standard sensors when performing 9-point mapping, the control panel will be flagged as exceeding the permissible threshold for errors.
Jeiotech microclimate chambers have an intelligent temperature and humidity threshold detection sensor system
2.2. Climate Range Recovery Time Not Achieved
A hardware parameter often overlooked in the test table is the thermal and humidity recovery time (Recovery Time). This is the time required for the system to compensate for the loss of microclimate after opening the door. Typically, the technical operating procedure stipulates that the cabinet door should not be opened for more than 30 seconds.
If the equipment’s air distribution system is too weak, a prolonged recovery time will cause thermal shock. This sudden fluctuation directly damages the physicochemical structure of the aging test sample. Therefore, this measurement item must be included in the periodic quality monitoring process.
3. Violations of Standard Linkage in Calibration
3.1. Selection of Incompetent Service Providers
Measurement standard linkage is a prerequisite for confirming the value of all analytical data. As stipulated in Section 6.5 of the standard, the laboratory must calibrate the equipment periodically. The mandatory calibration cycle for climate chambers and auxiliary measuring devices (such as independent hygrometers) is every 12 months.
However, many organizations hire external companies that do not have ISO 17025 certification to perform this. This legal error renders the accompanying calibration certificate completely worthless before the audit team. Therefore, we need to choose reputable national metrology testing centers.
3.2. Ignoring the Correction Value on the Certificate
Another very common systemic error is that technicians only save the certificate in their files for the sake of appearances. They completely ignore reading and applying the Correction Value to actual operation. This causes the equipment to always run with a fixed cumulative error over time.
We need to obtain correction data from the testing agency (e.g., Quatest) to set the offset value on the screen. To assist purchasing staff in preparing cost estimates, here is a table of “reference” calibration costs in Vietnam:
| Microclimate Chamber Capacity | Estimated Service Price (VNĐ) | Suggested Service Provider |
| Under 200 Liters | 2,500,000 – 3,500,000 | Regional Testing Centers |
| From 500 to 1000 Liters | 4,500,000 – 6,000,000 | Quatest 1 / Quatest 3 |
4. Violations of the ICH Standard Microclimate Range
4.1. Deviation from the Drug Stability Test Range
In the pharmaceutical industry, the environmental conditions for storing test samples are strictly regulated. The Vietnam Drug Administration requires factories to comply with stringent international guidelines. Therefore, we need to clearly understand the ICH Q1A (R2) standard for microclimate chambers in climate zone IVb.
This standard requires the long-term sample storage chamber to continuously maintain a temperature of 30°C ± 2°C and humidity of 75% RH ± 5% RH. If the chamber’s control system drifts beyond the threshold for more than 24 hours, the entire drug sample will deteriorate. The consequence is that the company has to completely discard the research data, causing significant economic losses.
4.2. Formation of Dead Climate Zones
In addition, low-quality chambers often experience serious aerodynamic structural errors. The lack of a high-performance convection fan system creates dead zones. In these dead zones, the actual parameters differ significantly from the values displayed on the control panel.
This condensation leads to a series of serious technical errors in the laboratory:
Premature drying of Petri dishes, killing the target microorganisms being cultured.
Incorrect results of accelerated aging tests of polymer materials.
Localized rusting on the surface of electronic components being tested for durability.
5. Data Integrity Security Vulnerabilities
5.1. Lack of Software Audit Trail Features
The digital age demands that laboratories strictly secure electronic data sources. International standards stipulate that equipment management software must adhere to the principle of data integrity. However, many older models often lack this core Audit Trail feature.
Experts would flag a serious NC (Non-Corrected) error if the software allows users to arbitrarily delete or modify raw data. We should proactively learn how LC DataKeeper increases data reliability on the microclimate chamber to securely synchronize data according to FDA 21 CFR Part 11 standards. This technical solution completely prevents any unauthorized interference with the original temperature and humidity chart.
Jeiotech autoclaves comply with FDA21 CFR Part 11 regulations
5.2. Sharing a Common Device Control Account
Another extremely common operational vulnerability is the use of a single system password. When an out-of-control (OOS) incident occurs, the lab management completely loses track of individual responsibility. Quality standards require us to tier individual account security into three independent levels:
6. Hardware and Safety System Structural Faults
6.1. Glass Condensation and Wall Rusting
When establishing equipment review criteria, the mechanical material structure is a decisive factor in durability. If the inner walls of the climate chamber are made of low-quality stainless steel, the high humidity environment will cause rapid rusting. This rust directly creates conditions for microorganisms to adhere, causing cross-contamination of samples.
At the same time, the lack of heated glass door technology will cause dense condensation. Technicians are forced to open the chamber door to observe samples, disrupting the stable climate range. Therefore, the cabinet’s interior structure must be cast from high-grade SUS304 steel, as exemplified by the robust hardware structure of the Model TH-TG-1000 temperature and humidity test chamber. This device integrates an intelligent controller and natural evaporation membrane technology to completely eliminate condensation.
6.2. Lack of Fire and Explosion Safety Barriers
Besides measurement factors, electrical safety risks are also a reason why microclimate chambers fail inspection. Cheaper, mass-produced chambers often omit sensors protecting the electrical circuit system. We need to proactively check the following core safety barriers:
Automatic circuit breaker (ELCB) to prevent voltage leakage to the casing, protecting technicians.
Independent dual overheat protection that automatically cuts off the heating element power in case of a short circuit.
Automatic low water level sensor to prevent dry burning that could cause fire and explosion in the humidity chamber.
7. Lack of a suitable work process handling procedure
7.1. Ignoring the sample isolation procedure when OOS occurs
Human response capabilities when equipment malfunctions are a crucial audit aspect. According to Section 7.10 of the standard, the lab must have a procedure for managing non-conforming work processes. When the microclimate chamber signals a deviation from the threshold, technicians often make the mistake of continuing to operate the machine.
Failure to isolate the test sample and post a warning sign to stop using the equipment is considered a serious system fault. In addition, the lab must be equipped with an independent data logger powered by a backup battery. This device allows us to continue monitoring raw environmental conditions when the building’s power grid is suddenly cut off.
7.2. Four-step environmental fault reporting procedure
To demonstrate quality control capabilities to VILAS experts, all environmental incidents must be fully documented. We need to strictly adhere to the following 4-step standardization process:
Rough recording: Immediately record the exact time of the incident and the actual temperature and humidity deviation range.
Equipment isolation: Safely move all test samples to the backup chamber and label the faulty machine for decommissioning.
Risk assessment: Collaborate with QA to analyze whether the deviation incident altered the physicochemical properties of the sample.
Correct action: Create a CAPA report and contact the technical solution distributor for hardware repair.
Conclusion
Identifying and proactively correcting core measurement errors in the quality control chamber is extremely crucial. This not only helps our laboratory successfully pass the VILAS accreditation but also protects data integrity in the long term. Owning a high-end sample storage device like the TH-TG-1000 Jeiotech model from South Korea is the most secure long-term investment. Contact Duc Duong Company now to receive the best price quote!
DUC DUONG SCIENCE AND TECHNOLOGY COMPANY
Address: 1014/67 Tan Ky Tan Quy, Binh Hung Hoa Ward, Binh Tan District, Ho Chi Minh City
Tel: (028) 3762 8042 – 3762 8043 – 3750 8514 – 3750 8793
Fax: 028 37628043
Email: ducduong@ducduongco.com
Website: ducduongco.com
ZALO OA: DUC DUONG SCI
