Steam validating installation every time. Construction.



Steam validating installation every time

Steam validating installation every time

In the high purity process industry, specifically the biopharmaceutical industry, documentation requirements are a key distinguisher between people who play in the industry and those that live in it. One of the most critical processes our customers trust us with is welding of material to create the fluid transfer paths that carry their products. Weld inspection and logging has been and will always be a key part of any Quality Assurance program. This post will focus on proper weld documentation specifically weld logs and weld maps- what they are and what information they provide.

Weld maps are isometric drawings of the assembly to be welded showing the location with each weld, each weld having its own unique identifying number. They also contain a bill of material with the part number of each component used in making the assembly. After each weld is completed, it is labeled with a weld number usually pin stamped on the part that corresponds to a number on the isometric drawing of the part.

When the isometric drawing is reviewed during validation, a third party can use the weld map to quickly identify where on the process piping the weld was performed and then refer to the weld log to ascertain the data discussed above. Weld logs contain the data specific to each individual weld. Normally a weld log sheet would contain all of the welding information for the welds on a specific isometric drawing. For our weld logs, the main body of the document has 9 columns for the weld to complete and 3 for the weld inspector.

For each weld, the welding technician first enters the weld number, the date, what piece of welding equipment is being used and which weld procedure is being used. They then enter the heat number for each of the two components to be welded, the size of the tubes being welded and their own initials. The rest of each line on the weld log is used by the weld inspector. Each weld is visually inspected by a qualified weld inspector using a boroscope to examine the weld ID.

Typical Holland Weld Log Once this process is completed, these documents, as well as the corresponding material test reports of the components used in the assembly, become part of the turn over package that ships with the system.

Properly executed, you now have a comprehensive package identifying each weld, who made the weld, what components went into the weld and the corresponding material certs for each one of the components.

The systems we fabricate at Holland Applied Technologies are used by our customers to manufacture drug products we literally inject into our bodies. And before the drug ever gets made, the system used to make it needs to be validated.

Governing bodies like the US Food and Drug administration use the data provided in these logs and maps to approve the manufacturer and manufacturing facility, protecting public health and giving consumers the peace of mind that the medicines they are taking are made on systems and in facilities that comply with current best practices.

So if after reading this blog, you have any questions about high purity process welding or documentation requirements, contact a Holland Sales Engineer today.

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STEAM REDOWNLOADING THE ENTITE GAME FILES EVEN AFTER DISCOVERING THEM SOLVED



Steam validating installation every time

In the high purity process industry, specifically the biopharmaceutical industry, documentation requirements are a key distinguisher between people who play in the industry and those that live in it. One of the most critical processes our customers trust us with is welding of material to create the fluid transfer paths that carry their products. Weld inspection and logging has been and will always be a key part of any Quality Assurance program.

This post will focus on proper weld documentation specifically weld logs and weld maps- what they are and what information they provide. Weld maps are isometric drawings of the assembly to be welded showing the location with each weld, each weld having its own unique identifying number. They also contain a bill of material with the part number of each component used in making the assembly. After each weld is completed, it is labeled with a weld number usually pin stamped on the part that corresponds to a number on the isometric drawing of the part.

When the isometric drawing is reviewed during validation, a third party can use the weld map to quickly identify where on the process piping the weld was performed and then refer to the weld log to ascertain the data discussed above.

Weld logs contain the data specific to each individual weld. Normally a weld log sheet would contain all of the welding information for the welds on a specific isometric drawing. For our weld logs, the main body of the document has 9 columns for the weld to complete and 3 for the weld inspector. For each weld, the welding technician first enters the weld number, the date, what piece of welding equipment is being used and which weld procedure is being used. They then enter the heat number for each of the two components to be welded, the size of the tubes being welded and their own initials.

The rest of each line on the weld log is used by the weld inspector. Each weld is visually inspected by a qualified weld inspector using a boroscope to examine the weld ID. Typical Holland Weld Log Once this process is completed, these documents, as well as the corresponding material test reports of the components used in the assembly, become part of the turn over package that ships with the system. Properly executed, you now have a comprehensive package identifying each weld, who made the weld, what components went into the weld and the corresponding material certs for each one of the components.

The systems we fabricate at Holland Applied Technologies are used by our customers to manufacture drug products we literally inject into our bodies. And before the drug ever gets made, the system used to make it needs to be validated. Governing bodies like the US Food and Drug administration use the data provided in these logs and maps to approve the manufacturer and manufacturing facility, protecting public health and giving consumers the peace of mind that the medicines they are taking are made on systems and in facilities that comply with current best practices.

So if after reading this blog, you have any questions about high purity process welding or documentation requirements, contact a Holland Sales Engineer today.

Steam validating installation every time

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4 Comments

  1. Design Systems Inc will assist our customer to optimize their BOP Basic Oxygen Process by developing a simulation to accurately depict the entire process from the blast furnace through the continuous casting line.

  2. We offer a full breadth of services for the manufacturing world, including conveyor engineering, industrial engineering, lean manufacturing, controls engineering, paint finishing engineering, simulation, 3D design, and program management. DSI is an industry leading supplier of simulation services.

  3. The Sand Handling System modifications will include providing electrical sequence of operations, field device layouts, control logic modifications and system start-up assistance. Design Systems providing ventilation and utility designs for major automotive powertrain facilities. The systems we fabricate at Holland Applied Technologies are used by our customers to manufacture drug products we literally inject into our bodies.

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