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In fields such as pharmaceuticals and scientific research where hygiene and safety are of utmost importance, the autoclave is undoubtedly the "loyal guardian" of sterile environments. However, do you know how to ensure that this critical equipment consistently operates accurately and efficiently? The answer lies in the mysterious yet crucial 3Q verification. Today, let's unveil the mystery of autoclave 3Q verification, explore the secrets and value behind it, and see how it protects our health and experimental results.
GMP (Good Manufacturing Practice) is a set of internationally recognized quality and safety standards designed to guide the production processes in industries such as pharmaceuticals, food, cosmetics, and medical devices. GMP outlines the entire process from design, production, packaging, to storage and transportation, ensuring that products meet specified standards for safety, purity, and quality.
One important aspect of GMP certification and review for pharmaceutical companies is the 3Q verification of instruments and equipment.
A complete instrument and equipment verification plan typically includes four parts, known as 4Q. These four parts are:
DQ (Design Qualification): Ensures that the design of the equipment meets user requirements and relevant regulatory standards.
IQ (Installation Qualification): Conducted during the installation process at the user's site, providing documentation to prove that all specifications and parameters of the user installation environment fully comply with the manufacturer's description and safety requirements.
OQ (Operational Qualification): Conducted after installation and repeated at regular intervals recommended by the manufacturer and confirmed by the client. It provides documentation to prove that during use, all functional parameters of the equipment components meet the manufacturer's specifications and operate normally.
PQ (Performance Qualification): Demonstrates that the equipment system is suitable for performing specific tasks, usually using the user's samples according to the user's method specifications.
In actual verification processes, only IQ, OQ, and PQ verifications are generally conducted, commonly referred to as 3Q verification.
Pre-verification Preparation
Preliminary research, validation conditions and process confirmation, drafting and coordination of the validation plan, pre-calibration of validation temperature probes, and review and signing of the validation plan.
Specific Verification Tasks
Installation Qualification: Confirm related information and documents of the instrument, and installation conditions, to ensure the instrument can be put into use.
Operational Qualification: Confirm whether the various operational functions of the instrument can be realized normally, and whether the instrument's metering and counting functions meet respective national standards.
Performance Qualification: Confirm whether the instrument's load operation meets the standard requirements. Performance validation is the core part of 3Q verification and mainly includes three aspects: no-load thermal distribution test, load thermal penetration, and microbiological challenge test.
As an important part of GMP certification and review, Zealway engineers hold KAYE verification qualifications, providing 3Q verification services for each autoclave.
Choosing Zealway's 3Q verification service means choosing professionalism, precision, and peace of mind. With our extensive technical knowledge and vast practical experience, we are committed to providing you with high-standard autoclave verification services. Our professional team will ensure that every detail complies with industry standards, ensuring that your equipment performs optimally. Choose Zealway, and pursue excellence with confidence and peace of mind.
Zealway is committed to being the best autoclave manufacturer globally, focusing on the research, manufacture, application, and service of sterilization equipment for over 20 years. We are dedicated to providing one-stop solutions for customers who have higher requirements for safety, quality, and performance.
