Pharmaceutical Laboratory Equipment
制药
Sector PHA · 5 categories · 23 product types
By Lab Manufacturers China Technical TeamLast reviewed
What is Pharmaceutical?
The Pharmaceutical sector covers laboratory equipment for testing drug substances and finished dosage forms against pharmacopoeial and GMP requirements. It includes dissolution, disintegration, hardness and friability testers, pharmaceutical analysis instruments and drug testing equipment used in quality control, formulation development and regulatory release.
5 categories in Pharmaceutical
Browse the 5 categories, then the product types and models inside them.
Pharmaceutical laboratories test materials and products against defined specifications, and the results support batch release. Equipment must therefore perform to tolerances set out in the pharmacopoeias, and its qualification and calibration must be documented.
This sector focuses on dissolution testing equipment designed around USP <711> and Ph. Eur. 2.9.3 apparatus types, tablet testing equipment for hardness, friability, disintegration and thickness, pharmaceutical analysis equipment such as HPLC and UV-Vis systems configured for QC work, and drug testing equipment for content and impurity determination. Related general equipment, such as stability chambers, balances and purified water systems, is found in other sectors.
Selection criteria include compliance with USP, Ph. Eur. and JP apparatus specifications, vessel and shaft tolerances, temperature control, automation of sampling, and software features that support 21 CFR Part 11 and data-integrity expectations. For regulated users, installation, operational and performance qualification documents are often a purchase requirement.
Products are offered by a Chinese manufacturer and exporter. Suitability for a specific monograph or regulated use is to be confirmed with the supplier, and qualification protocols are scoped at quotation.
Applications
Industries that specify Pharmaceutical equipment.
Frequently asked questions about Pharmaceutical
Common tablet QC equipment includes a hardness (breaking force) tester, friability tester, disintegration tester, dissolution tester, thickness gauge, analytical balance and HPLC or UV-Vis for assay. Which tests apply is defined by the product monograph and the pharmacopoeia you follow.
USP apparatus 1 uses a rotating basket to hold the dosage form, while apparatus 2 uses a rotating paddle with the dosage form resting at the bottom of the vessel. The monograph specifies which apparatus, medium volume and speed to use.
IQ and OQ protocols and factory test records can usually be discussed at quotation, together with calibration certificates for critical sensors. Scope, format and any charges are confirmed per project. Performance qualification is typically completed on site with the user's own procedures.
Software-controlled systems may offer audit trails, electronic signatures and user access levels intended to support Part 11 and data-integrity practices. Compliance depends on configuration and the user's procedures, so confirm software features and validation support with the supplier before purchase.