How to define the boundaries of equipment and verification work in the air-conditioning box of pharmaceutical clean workshop?

The pharmaceutical clean workshop should define the air-conditioning box equipment delivery, system debugging and confirmation verification separately. The materials, configurations or factory records provided by the manufacturer can become part of the project information, but one piece of equipment or one factory report cannot be relied upon to conclude that the entire workshop has been confirmed and verified.

Responsibilities are assigned to documents item by item based on user needs

State the equipment service scope, key parameters and data requirements in the user demand document, and then agree on the tasks to be undertaken by the equipment manufacturer, installer and user respectively. The equipment side can deliver drawings, parts lists, operation and maintenance and agreed test records; the system side also involves on-site installation, air volume distribution, control linkage and actual usage conditions.

Equipment delivery must check the model, material, configuration, drawings and factory records; on-site work must check the installation interface, system debugging and on-site test scope; for confirmation and verification, the project quality system will determine the plan, evidence and approval responsibilities. The three types of work correspond to different responsible entities and cannot be lumped together in one equipment list. What information should be prepared before selecting an air-conditioning box? Please refer toWhat project information should be prepared before selecting an air-conditioning box?。

Where are the boundaries of equipment delivery?

Equipment delivery usually includes the unit itself, agreed accessories, random information and factory inspection records. Material certification, filter grade, coil configuration, control cabinet range and interface size are contents that can be confirmed on the equipment side. What cannot be replaced on the equipment side is the system air volume balance, room pressure difference, actual cleanliness measurement and process environment verification after installation.

Procurement technical documents should list applicable standards and delivery evidence, please refer toWhat applicable standards should be listed in the technical documents for purchasing air-conditioning boxes? . For the difference between box test and complete machine performance test, please refer toWhat is the difference between air conditioning box body test and complete machine performance test? . Equipment factory records should correspond to specific models and configurations, rather than generic samples.

System debugging is an on-site joint work

System debugging involves air volume balance, waterway balance, control linkage and operating parameter setting, and is usually completed by the installer, equipment side and user. The equipment party can provide debugging guidance, interface verification and parameter suggestions, but the project party is responsible for site conditions, air duct installation and terminal distribution.

How to change the debugging sequence from stand-alone to system linkage, please refer toHow to change the debugging sequence of air conditioning box from stand-alone unit to system linkage? . For condition checks before starting the machine for the first time, please refer toWhat conditions need to be checked before the air conditioner is turned on for the first time? . The results of air volume balance and pressure difference adjustment should be included in the commissioning records.

Confirmation verification is led by the project quality system

The verification plan, evidence and approval responsibilities are determined by the pharmaceutical project quality system. Equipment manufacturers can provide material documents, parts lists, factory test records and operation and maintenance instructions as part of the verification information, but they cannot complete installation confirmation, operation confirmation and performance confirmation on behalf of the project party. Sampling points, testing methods, and acceptance criteria for verification should be determined by the project quality team in accordance with applicable regulations and internal procedures.

For equipment-side filtration and clean air supply packages, please refer toHEPA/ULPA filters withFFU fan filter unit . When it comes to gaseous pollution control, you can communicate separatelyChemical filter solutions. Whether the high-efficiency filter is placed inside the machine or at the end will affect on-site leak detection and verification arrangements. Please refer toShould the high-efficiency filter of the air-conditioning box be placed inside the machine or at the end of the air supply?。

Check how the data will be used before purchasing

If the project requires the manufacturer to cooperate with specific tests or file formats, the methods, witness arrangements and responsibilities should be written into the technical agreement in advance. Unagreed system-level tasks cannot be converted into equipment shortages after delivery. Specific applicable requirements are confirmed by the project quality and professional team, and equipment selection cannot replace these judgments.

When third-party testing or specific certification is required, the object, scope and cost responsibilities should be explained during the inquiry stage. Please refer toHow to write an inquiry form for air-conditioning boxes so that different quotes can be compared? . Version management of equipment data and verification documents should also be included in project document control.

Operation and maintenance information is part of the delivery

Operating and maintenance instructions, filter replacement requirements, sensor calibration recommendations and spare parts lists form part of the equipment delivery documentation. This information will be referenced during validation and subsequent operations. When the data is incomplete, it will be difficult for the user to maintain the equipment according to the requirements, and it may also affect the maintenance of the verification status.

For filter classification configuration and pressure difference monitoring, please refer toHow to configure the primary-efficiency and medium-efficiency filters of air-conditioning boxes in different stages? . For control point table and alarm definition, please refer toWhat point tables need to be provided before the air-conditioning box is connected to the building automation system?。

Aili industrial supporting equipment

When communicating with Aili Industrial about pharmaceutical projects, you can first submit a list of user requirements and information, and confirm the equipment evidence that can be provided and the work that needs to be completed by other participants one by one. Aili's industrial manufacturing end covers independent R&D and production of motors and fans, control systems, sheet metal, air filters and complete machine assembly. Equipment models, materials, configurations and random information can be corresponded in the same set of delivery documents; records of non-standard configurations can be kept to facilitate the inclusion of verification information by the project party.

Product form can be viewedAir handling unit andFan box page; clean air supply package can be combinedFFU fan filter unit andEFU equipment end fan filter unit verification; terminal particle filtration can be combinedHEPA/ULPA filter confirmation; when it comes to gaseous pollution control, you can communicate separatelyChemical filter solutions. Specific equipment evidence, verification division of labor and delivery scope still need to be confirmed based on the project contract, quality system and on-site working conditions.

Submit project parameters:https://ailigy.com/contactus.html

Related questions and answers

If the manufacturer provides a factory report, does it mean that the verification has been completed?
Not equal to. The factory report is part of the equipment evidence. Installation confirmation, operation confirmation and performance confirmation still need to be completed by the project quality system according to the plan.

Does the equipment manufacturer need to participate in on-site debugging?
Usually, debugging guidance, interface verification and parameter suggestions are provided according to the contract. On-site air volume balance and control linkage are jointly completed by all parties to the project.

What pharmaceutical project information can Aili Industrial provide?
Equipment drawings, material and configuration records, operation and maintenance instructions and other information can be provided according to the agreed scope. The specific list needs to be confirmed based on the project user needs and the contract.

Related articles

1. What project information should be prepared before selecting an air-conditioning box?

2. What applicable standards should be listed in the technical documents for purchasing air-conditioning boxes?

3. How to change the debugging sequence of air conditioning box from stand-alone unit to system linkage?

4. What conditions need to be checked before the air conditioner is turned on for the first time?

Key points for selection and acceptance inspection