Tender procurement
LIZHU Group LIZHU Pharmaceutical Factory Sterile Vial Capping Equipment Bidding Announcement
Release time:
2024-05-11
Our company intends to conduct bidding for the following procurement project. We welcome units with good bank credit and financial status, meeting qualification requirements, and having similar project achievements to participate in the bidding. The relevant matters of this project are announced as follows:
1. Introduction to the bidding project
(1) Project Name: Procurement Project for Sterile Production Capping Equipment of Livzon Group Livzon Pharmaceutical Factory
(2) Project Implementation Location: Livzon Pharmaceutical Factory
(3) Procurement Content (Scope of Work): 2 capping machines and supporting tracks and discharge devices;
(4) Quality requirements for this bidding project:
The capping machine should be able to meet the production of 2mL to 80mL vials at a speed of 400 bottles/min, linked with existing in-and-out equipment, ensuring a natural connection of the linkage line, smooth operation, preventing collisions, and avoiding broken bottles, tipped bottles, and exploded bottles. When a blockage or failure occurs downstream, the capping machine can protect itself by stopping.
1) It must have batch production records and summary functions, with batch record content complying with current WHO, EU, FDA, and China GMP regulations.
2) The capping machine's pressing head or bottle support block must be equipped with pressure detection, using a cylinder form to ensure balanced pressure for each capping head.
3) A probe should be set at the back end of the capping to detect capping conditions. When it detects five consecutive uncapped situations, it should immediately stop or alarm to avoid issues such as aluminum cap deformation causing the lower aluminum cap to be unsteady, leading to excessive waste.
4) Capping should be smooth and accurate, with no jumping caps, no reverse caps, no stuck caps, and no delayed lower caps, with a successful capping rate of ≥99.9%. In case of reverse caps, stuck caps, or delayed lower caps, an alarm should be triggered to stop the machine, and an aluminum cap color identification alarm should be configured (aluminum caps that do not match the color used for that batch of products should trigger an alarm).
5) The lower cap position of the capping machine track should have a good lower cap sensing device. When the lowest end is missing a cap, it should immediately stop to avoid producing uncapped products.
6) The capping machine and supporting track should be equipped with a linkage control device. If one of the two capping machines fails, it can quickly switch to the other for production. In emergency situations, manual or emergency operation control is possible.
7) The vial conveying system should operate smoothly at the maximum speed of the capping machine, with a bottle tipping rate on the conveying track of less than 0.05%, and should not cause scratches or other defects on the bottle's appearance; the design should be reasonable, and components should be easy to clean and disinfect, allowing for specification changes without special tools.
8) The specification parts of the capping machine should use designs such as positioning pins to facilitate quick and easy replacement, with high precision and strong interchangeability, minimizing or reducing the use of tools; molds should not deform due to various environmental factors such as temperature and humidity, and the mold replacement time for each machine should be ≤2hr/person.
9) Detection of missing plugs and bottle bodies should be sensitive, equipped with disqualification removal devices, and have functions for no bottle no lower cap, no plug no lower cap, no bottle no capping, and no plug no capping.
10) The capping machine should have reasonable designs for feeding, entering caps, lowering caps, and capping, facilitating the operation of adding aluminum caps. The transfer of aluminum caps to the capping station should avoid the generation of particles, and there should be reasonable dust removal and collection devices for metal particles and broken bottle debris generated at the capping station.
11) Internally integrated installation of online particle and airborne bacteria monitoring system interfaces. The monitoring results of the particle counter should be recordable and reflected in reports. The particle counter should have an over-standard alarm mechanism, with pre-warning and alarm limits set according to the requirements of the party.
12) It should have a product specification memory function, allowing the system administrator to set, store, and call up no less than 99 production product process parameters (programs) on the operation interface according to production process requirements. The process parameters should include product name, batch number, production date, capping start and end time, finished product quantity, production speed, etc. The process parameters should be displayed on the operation panel and can operate within the set parameters, with good stability and repeatability of the system.
13) The display control part of the capping is located outside the RABS, easy to operate; convenient for viewing and capable of remote data printing. Electronic data (data records, alarm records, audit trail records, etc.) should be automatically backed up regularly.
14) Other functional requirements can be found in the equipment URS.
(5) Equipment delivery period (construction period): 90 days FAT
2. Qualification requirements for bidders and required submitted materials
1. A legal enterprise with a valid business license and qualification certificate, capable of independently assuming civil liability, with last year's operating income not less than 30 million yuan, able to send a technical person to the project site for inspection and technical inquiries within the specified time;
2. Materials to be submitted for registration: Legal person authorization (entrustment) letter, copies of the legal person and authorized person's ID cards, copies of the business license, copies of qualification certificates, copies of contracts, annual financial statements, contact person and communication methods (the above copies must be stamped with the official seal of the unit); equipment technical materials, list of domestic customers, etc.
3. Registration and qualification pre-review
(1) Registration time: Deadline is 10 days from the date of posting
(2) Registration method: Send registration materials to the dedicated email for bidding registration (please indicate the name of the bidding project)
(3) Dedicated email for bidding registration: xietingting@livzon.cn
(4) Registration contact phone: Xie Tingting 0756-8135096
(5) Qualification pre-review: Our company will conduct a qualification pre-review based on the bidder's registration materials, and will provide written feedback and confirm bidding qualifications for potential bidders that meet the requirements. The acquisition of bidding documents and the bidding deadline will be notified separately by the bidder.
(6) Qualified bidders should register as qualified suppliers in the Livzon Group SRM system (http://srm.livzon.cn/). For details, see the "Supplier Registration Operation Manual" on the official website.
4. This bidding is supervised by the Group Risk Management Headquarters, and the relevant contact information is as follows:
Reporting Contact: Mr. Xu
Reporting and complaint fixed phone: 0756-8135383
Reporting email: xudan01@livzon.cn
Livzon Group Livzon Pharmaceutical Factory
May 11, 2024