What is the ASME-BPE Standard?

 

The American Society of Mechanical Engineers Bioprocessing Equipment (ASME BPE) is regarded as an international standard that regulates the equipment designs employed in bioprocessing, pharmaceutical, and industries that require a high level of hygiene.

It often deals with designs, materials, inspections, fabrication, certification as well as testing of equipment.

ASME BPE is essential and a leading standard that stipulates the standards to be followed in the design and fabrication of bioprocessing and pharmaceutical equipment by incorporating the best practices aimed at enhancing the safety and purity of products manufactured.

Through ASME BPE standard, companies can attain production efficiencies, minimize manufacturing costs, lower development, and increasing safety and quality of products while at the same time complying with the set regulations.

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Historical background of ASME-BPE

 

The history of the ASME BPE standard can be traced back to 1997 when the ASME first published the standards for bioprocessing equipment.

Until then, there were no regulatory standards directed towards the requirements and needs for equipment used in the bioprocessing and pharmaceutical industries.

However, by harmonization and scrutinization efforts, the ASME incorporated acceptable methodologies while working together with FDA regulatory requirements provided a set of standards that are vital and integral to the bioprocessing and pharmaceutical industries.

The development of this standard allowed harmonization of various other standards thereby preventing conflicts and omissions between various related standards. Ever since the establishment of this standard, it has been constantly updated through 2002, 2005, 2009, and lastly in 2016 based on the technological advancements in the aforementioned industries.

 

Overview of the ASME BPE standard

 

The ASME BPE standard is categorized into 10 sections that address the requirements for various systems and production units. An overview of the ASME BPE standards is described herein.

 

1. General requirements: This part describes a review of laws and standards that various manufacturers should comply with when utilizing pressurized equipment.
2. System design: This section outlines clean ability and bio burden control required for various system’s processes, utilities as well as components used.
3. Process instrumentation: This section addresses the instrumentation required for flow rate control, temperature control, and pressure instruments, among others.
4. Dimensions and tolerances for process equipment: This part outlines topics including the wall thinness of equipment, pressure rating, and hygiene clamp union.
5. Metallic materials: This part provides information details of various alloys, outlines different types of metallic materials and to a larger extent gives specific details of ferrite levels and sulfur content requirements.
6. Material joining: In this section, various material joining practices are described in detail. These include acceptable discoloration at welded parts.
7. Polymeric and non-metallic materials: This section outlines the leachability and compatibility of various polymeric and non-metals.
8. Sealing components: This part addresses the requirements for seals, valves, and fittings. It outlines the details regarding static seals such as hygienic unions and O-rings. It also provides requirements for dynamic seals such as diaphragm valves and dual mechanical seals.
9. Product contact and surface finishes: This section specifies the required surface finishes for various components of the system. It also gives details regarding passivation and electropolishing.
10. Certification: This section provides information regarding how companies may obtain the ASME BPE certification and outlines the requirements that may change over time. As such, for fitting and tubing manufacturers, this section provides a primary distinction in terms of requirements.

 

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Much more than just a standard

 

In conclusion, the ASME BPE standard has played a critical role in the betterment of the pharmaceutical and bioprocessing industry at large. It, therefore, remains an essential factor in the development of new and improved products. Based on the various processes of operation, various sections of the ASME BPE standard apply. It is therefore important to adhere to the stipulated regulations to ensure the safety and quality of products manufactured through various bioprocessing and pharmaceutical equipment.

 

 

ASME-BPE Tube dimensions

Size	Dimensions (mm)
1/2"	12,7 x 1,65
3/4"	19,05 x 1,65
1"	25,4 x 1,65
1 1/2"	38,1 x 1,65
2"	50,8 x 1,65
2 1/2"	63,5 x 1,65
3"	76,2 x 1,65
4"	101,6 x 2,11
6"	152,4 x 2,77

 

 

ASME-BPE fittings codes

 

The fittings that you can use in an ASME-BPE system have been given a designation code. With this code you can be sure that you have the right part.

As you can see in the table, the tri-clamp parts and also the butterfly valves do not have a part number. However, they are included in this table because they are very often used in combination with ASME-BPE tubing.

 

ASME-BPE Code	Fitting type
DT-4.1.1.1	Elbows 90° - Welding ends
DT-4.1.1.2	Elbows 90° - Welding end x Tri clamp
DT-4.1.1.3	Elbows 90° - Tri clamps
DT-4.1.1.4	Elbows 45° - Welding ends
DT-4.1.1.5	Elbows 45° - Welding end x Tri clamp
DT-4.1.1.6	Elbows 45° - Tri clamps
DT-4.1.1.7	Return bends 180° - Welding ends
DT-4.1.1.8	Return bends 180° - Tri clamps
DT-4.1.2.1	Straight tees - Welding ends
DT-4.1.2.1	Straight crosses - Welding ends
DT-4.1.2.2	Short outlet tees - Welding ends x Tri clamp
DT-4.1.2.3	Short run outlet tees - Welding ends x Tri clamp
DT-4.1.2.4	Straight tees - Tri clamps
DT-4.1.2.4	Straight crosses - Tri clamps
DT-4.1.2.5	Short outlet tees - Tri clamps
DT-4.1.2.6	Reducing tees - Welding ends
DT-4.1.2.7	Short outlet reducing tees - Welding ends x Tri clamp
DT-4.1.2.8	Reducing tees - Tri clamps
DT-4.1.2.9	Short outlet reducing tees - Tri clamps
DT-4.1.2.10	Instrument tees - Welding ends x Tri clamp
DT-4.1.2.11	Instrument tees - Tri clamps
DT-4.1.3.1	Concentric reducers - Welding ends
DT-4.1.3.1	Eccentric reducers - Welding ends
DT-4.1.3.2	Concentric reducers - Tri clamp x Welding end
DT-4.1.3.2	Eccentric reducers - Tri clamp x Welding end
DT-4.1.3.3	Concentric reducers - Tri clamps
DT-4.1.3.3	Eccentric reducers - Tri clamps
	Long type Tri clamp ferrule
	Short type Tri clamp ferrule
	Tri clamp rings
	Tri clamp seal rings
	Manual butterfly valves - Welding ends
	Manual butterfly valves - Tri clamps
	Pressure gauges - Bottom connection
	Pressure gauges - Rear connection
	Pressure gauges - Left side connection
	Pressure gauges - Right side connection

 

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