Applications In The Pharmaceutical Industry

Special Requirements for Pharmaceutical Tanks

One of the key distinctions between the pharmaceutical and food & beverage industries lies in the rigorous requirements for validation and documentation traceability. Tank manufacturers are typically required to provide a comprehensive validation documentation package, including: Functional Design Specifications (FDS), AutoCAD drawings, material certificates (3.1b certificates), welding procedure specifications, welder qualification certificates, isometric weld logs, weld ID markings, FAT (Factory Acceptance Test), IQ (Installation Qualification) and OQ (Operational Qualification) protocols, as well as complete data records.

Regarding cleaning validation, spray ball coverage testing (riboflavin testing) is a prerequisite for verifying tank cleanability, and the internal surface finish must meet design specifications. Cleaning validation requires the successful completion of at least three consecutive cleaning cycles and must include testing for parameters such as cleaning agent residues, microbial load, and bacterial endotoxins.

There is a wide variety of tank types in the pharmaceutical and biopharmaceutical industries

Requirements for tanks in the pharmaceutical and biopharmaceutical industries have risen to the level of sterility assurance, verifiability, and regulatory compliance.

Core Design Requirements

Parts in direct contact with the drug product must be made of 316L stainless steel, while other parts may use 304 stainless steel; material certification documents must be provided. Internal surface polishing requirements are extremely stringent: Ra ≤ 0.4 μm (mirror finish), with a matte finish of Ra ≤ 0.8 μm for external surfaces. Certain high-demand applications may even require Ra ≤ 0.28 μm. For high-end applications, electropolishing is also available, achieving a surface roughness of 0.1 μm Ra.

The tank must feature a design free of dead zones that allows for complete drainage; welded joints must be ground smooth and be free of cracks or crevices. The tank body and heads are to be formed with radiused corners (spun R-corners), and the discharge outlet must be equipped with an anti-vortex baffle; the unit must also include a spray ball and a breather valve. Pressure and vacuum ratings must meet process requirements; a typical liquid preparation tank is designed for a pressure range of -0.1 MPa to atmospheric pressure and a design temperature of ≥110°C.

All tanks must support CIP (Clean-in-Place) and SIP (Sterilize-in-Place) operations. They are equipped with components such as CIP spray balls, SIP sterilization ports, and sterile vent filters (with a filtration rating of 0.22 μm). The system-wide CIP/SIP process involves introducing cleaning fluid through the spray ball of the first tank and forcing it sequentially into the subsequent tanks, continuing up to the filling machine's buffer tank; pure steam is similarly introduced into the first tank and forced through the system to sterilize the tanks one by one.

Materials and Surface Treatment
Structural Design
CIP/SIP compatibility

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Technological development

1995-L&B Company formerly known as Sifang Machinery Factory, is a manufacturer of food and pharmaceutical pipe fittings and valves.
2002-The Company according to the demand of suppliers, eatablish a market brand, and change company name to Wenzhou L&B Co., LTD.
2003-In order to meet the needs of the development of the dimeatic market, the Company sorted out the enterprise resources and industrial chain resources, and established a branch office in Guangzhou.
2007-The Company changed its name to Wenzhou L&B Fluid Equipment Co,. LTD., with self-operated import and export rights, began to enter international trade.
2011-In order to further develop the international market, the Company registered and established the trade branch:Wenzhou Flowtam Light lndusty Machinery Co., LTD.
2012-The Company passed ISO9001 quality system certification,a number of products through the EU CE certification, Product quality and management level has a qualitative improvement. In the same year, the Company changed its name to Zhejiang L&B Fluid Equipment Co., LTD.
2016-The Company moved into the new factory equipped with high-tech equipment and CNC machining center for manufacturing high-end products: stainless steel tanks, sanitary high-viscosity transferning pump, etc, to achieve the pattern of product diversification, production automation, scale intensification.
2018-A number of stainless steel filters obtained German TUV and PED certification, thus paving the way for stainless steel Tanks and its related products to enter the EU market.
2019-The Company changed its English name to Zhejiang L&B Machinery Co., LTD.
2021-The Company is awarded the certificate of "national high-tech enterprise", and the ability of core inedpendent intellectual propetry rights and innovation ability have been further improved.
2022-The Company acquied Wenzhou Silong auto parts.(Wenzhou Therin Automotive Spare Parts Co,. Ltd).
2023-The Company moved into Oujiangkou Industrial Cluster, a new production plant, the new Company construction area of about 15,000 square meters. Newly built large Tank production workshop,large diameter tank automatic welding machine, multi-axis CNC machining center and other equipment. Provide hardware support for enterprises to become bigger, stronger and more refined.