White Paper Sanitary Connections in Pressure Relief

White Paper

Pipe connection designs have been a challenge for most design engineers working in the sanitary industries. To achieve clean processes and/or easy to clean piping arrangements a wide range of standard industry fittings and connectors have been introduced. With the focus on cleanliness and cleanability a variety of process fittings have also emerged. This paper addresses some of the issues which may affect an installations conceptual design and its fit-for-purpose level, especially when integrating specific process equipment such as rupture (bursting) disc devices. Specifically, we will address an installations sanitary level, optimization of the performance level of critical safety devices and Good Manufacturing Practice (GMP)

Connector Design & Selection Issues

To achieve acceptable performance and throughput within critical process plants, there are a number of issues to be addressed, each with a potential impact on the expected level of cleanliness and cleanability. Good Manufacturing Process The main strategy applied in these industries is known as Good Manufacturing Practice(GMP), or production and testing practices that help to ensure a quality product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created specific GMP guidelines that correspond with their legislation. Basic to all of these guidelines remains safeguarding the health of the patient, as well as producing good quality medicine, medical supplies or active pharmaceutical products. In the U.S. a drug may be considered adulterated if it passes all of the specification tests, but is found to be manufactured in a condition which violates current good manufacturing guidelines. Therefore, complying with GMP is often considered as a mandatory aspect in pharmaceutical manufacturing. GMPs are enforced in the United States by the US Food and Drug Administration (FDA), under Section 501(B) of the 1938 Food, Drug, and Cosmetic Act (21 USCS 351). The regulations use the phrase current good manufacturing practices (cGMP) to describe these guidelines. Courts may theoretically hold that a drug product is adulterated if the process was not performed according to industry standards, even if there is no specific regulatory requirement that was violated. As of June 2010, a different set of cGMP requirements apply to all manufacturers of dietary supplements. The European Unions GMP (EU-GMP) enforces similar requirements to the U.S. FDA and the World Health Organization (WHO) version of GMP is used by pharmaceutical regulators and the pharmaceutical industry in over one hundred (100) countries worldwide (primarily in the developing world). Similar GMPs are used in other countries, such as Australia, Canada, Japan, Singapore and others having highly sophisticated GMP requirements.

Hygienic Design
When designing/operating a process plant or piece of equipment intended for food, beverage, pharmaceutical or biotech industries, a primary concern is the control and maintenance of the critical hygiene level. The consequence of an improper level of cleanliness or cross-contamination between batches, may create an even higher risk of potential casualties than from overpressure or explosions. Different approaches or solutions have been used/introduced, depending on the specific industry or application: Food-including standard consumer foods, healthcare nutrition, dietary & sports/energy foods, medical or orphan foods Pharmaceuticals Cosmetics Biochemical products Beverages Other Historically, designers and equipment suppliers have worked to create process equipment and installations which limit areas where bacteria can grow. In addition, the cleaning and inspection ability has often been optimized through the design and use of specific piping connections. These connections allow operators to easily disassemble, inspect and clean the piping elements prior to the start of production. As a result, various industry fittings have been designed and are in use throughout a wide number of industry applications. Because there are so many standard connection types, certain compatibility issues may exist and go unnoticed, affecting both production efficiency and product quality.
2

White Paper

Cleanability
Though there are specific requirements by industry, a common baseline is no contamination. The risk for contamination stems from a variety of sources such as: bacteriological, viruses, cross-contamination between subsequent batches, allergy-enhancing components, etc. Therefore, the ultimate objective of piping and equipment designers is to create products/systems which have no crevices or pockets where such contamination can initiate, and to have good cleanability and/or sterilization geometries. Standard operation for most of these industries is the highly efficient cleaning or sterilization of the surfaces and connections exposed to the media. Clean-In-Place (CIP) and Steam-In-Place (SIP) are terminologies often used to refer to the process geometry configurations offering such enhanced cleaning & inspection features. CIP is a method of cleaning the interior surfaces of pipes, vessels, process equipment, filters and associated fittings, without disassembly. When the cleaning involves steam as the cleaning/rinsing media and the exposed equipment is also sterilized the operation is then referred to as SIP.
An example of a sanitary rupture/bursting disc, Fikes Axius SC is specifically designed for the stringent aseptic requirements of these applications. The Axius SC is free of indentations, crevices, or other design features that may trap process contaminants.

Some standards, such as ASME BPE, provide useful information with regards to recommended configurations of connections and piping, drain-ability and suitable L/D ratios. The EHEDGcertification guidelines provide evidence of suitable design and cleanability of approved components.

Inspection
To assure that the installation is fit for use, an optimal inspection of the equipments internal surfaces is required. Therefore, the pipe connectors need to be easy to disassemble, inspect and, where appropriate, clean and re-assemble. As a result of these requirements, the market has seen the emergence of a large variety of pipe connectors: Tri-Clamp or ASME BPE, DIN, SMS, ISO, NA-connect, etc. To the layman, some of these connectors (also called ferrules) may look identical; but there are minute differences in dimensions making it necessary to assure the correct combination is selected.

Compliance and suitability of equipment for the intended use is generally covered for the US markets by design validation through organizations such as 3A (American Aseptic Association, www.3-a.org ). In Europe the EHEDG (European Hygienic Engineers Design Group, www.ehedg.org ) provides design guidelines and validation testing for cleanability of equipment. Equipment found to be in compliance with the relevant requirements, bear these compliance symbols.
Clamp & Ferrule Type Connectors (ASME BPE, DIN 32676, ISO 2852, etc)

3A-Symbol

EHEDG-Symbol
3

White Paper

Compatible Materials
There are also existing and emerging requirements with regards to suitability of the used materials of construction, in regards to the intended purpose. For the US markets: FDA mainly dealing with acceptance of materials United States Pharmacopeial Convention (USP) - sets standards for the identity, strength, quality, and purity of medicines, food ingredients, and dietary supplements manufactured, distributed and consumed worldwide.

encephalopathy, also know as BSE- or mad cow disease). The unwanted risks related to migration of substances or active components are also addressed in order to reduce the risks for allergic reactions and other health issues.

Other Issues
The objectives of connector standardization are clear: provide a way to design and offer standard instrumentation and valves with suitable characteristics for use under the required operating conditions. However, due to historical developments, specific industry requirements and lacking harmonization, nearly identical standard fittings have been developed, oftentimes with only minute differences, whereas others will look dramatically different from others. In all installation geometries, a smooth, crevice free transition between the ferrule inside diameter and the gasket, needs to be achieved. A common misunderstanding with specifying engineers or users is to refer to the sanitary tube specification used (SMS3008, DIN 11850, ASTM A270, etc), while addressing the ferrule. The pipe intended to be welded to the ferrule must have identical dimensions (inside and outside diameter) to the but-weld end of the corresponding ferrule in order to achieve a smooth transition between ferrule and pipe. However, ferrules from several executions and standards have been designed to fit with the same tube dimensions. It is essential that the correct ferrule is clearly selected and specified.

For the European markets: European Regulations (such as Regulations 1935:2004 and 2023:2006) - deals not only with material acceptance, but quality and traceability systems applied in the manufacturing of components and complete assemblies. Regulation 2023:2006 is also referred to as the European GMP document.

In general, most metallic parts manufactured from stainless steel or nickel alloy, are accepted for use in sanitary processes. The use of non-metallic parts such as gaskets, coatings or active substances are often a more challenging issue. Not only is compatibility required, but the traceability of the manufacturing process and compounds used must be validated. This is critical not only for high-risk pharmaceuticals or orphan drugs, but is standard for food and beverage products to avoid contamination (such as with Bovine spongiform

Overview of Critical Dimensions for Common Ferrule Types

ASME BPE Dimensions Nominal Size 1 1.5 2 3 4
Inside Diameter Ferrule OD Gasket Centerline Nominal Size

DIN 32878 Dimensions

Inside Diameter Ferrule OD Gasket Centerline

ISO 2862/8MS 3008 Dimensions

Nominal Size Inside Diameter Ferrule OD Gasket Centerline

mm 22.10 34.80 47.50 72.90 97.38 50.39 50.39 63.91 90.91 118.92 43.64 43.64 56.34 83.34 110.34

mm 32.00 38.00 49.99 80.98 100.00 50.50 50.50 63.98 105.99 119.00 43.48 43.48 56.49 96.98 110.01

mm 35.59 37.59 48.59 66.78 72.90 50.50 63.98 63.98 90.98 90.98 43.48 55.49 55.49 83.49 83.49

32 40 60 80 100

38 40 61 70 76.6

Standard connections can be safely used within the pressure/temperature boundaries as specified for the subject connection type.

White Paper

Ferrule Product Information: Typical Ferrule Surface Finishes

Finish Code Alfa-Laval Tri-Clover #1 #3 #7 PC PD PL PM SFF1 SFF4 SFF1 SFF4 32 32 20 15 20 15 0.8 0.8 0.5 0.4 0.5 0.4 ASME BPE Maximum Surface Roughness
Microinches Micrometers

Media Contact Surface Polishing Method Unpolished Mechanically Polished Mechanically Polished Mechanically Polished Mechanically Polished & Electropolish Mechanically Polished Mechanically Polished & Electropolish

Non-Media Contact Surfaces

(m-inches)

(mm) Unpolished Polished to Ra 32 m-inches, 0.8 mm Unpolished Polished to Ra 32 m-inches, 0.8 mm

Maximum Recommended Operating Pressure Rating

Nominal Size 13MHLA at 70F/21C at 250F/121C 13MHHM at 70F/21C at 250F/121C 13 MHHS at 70F/21C at 250F/121C 13 MHP at 70F/21C at 250F/121C 500 psig/34.48 barg 1 & 1 1/2 Clamp Screw Tightened to Maximum 150 psig/10.3 barg 125 psig/8.6 barg Wing Nut Tightened to 25 in.lbs/2.82 Nm Torque 450 psig/31 barg 350 psig/24.1 barg 195 psig/13.4 barg 350 psig/24.1 barg 175 psig/12 barg 300 psig/20.6 barg 150 psig/10.3 barg 300 psig/20.6 barg 150 psig/10.3 barg 800 psig/55.1 barg 600 psig/41.3 barg 300 psig/20.6 barg Wing Nut Tightened to 25 in.lbs/2.82 Nm Torque 600 psig/41.3 barg 300 psig/20.6 barg 1500 psig/103.4 barg 1200 psig/82.7 barg 550 psig/37.3 barg 275 psig/18.9 barg 100 psig/6.8 barg 75 psig/5.1 barg 2 3 4

Bolts Tightened to 20 ft.lbs/27.1 Nm Torque 1000 psig/69.9 barg 800 psig/55.1 barg

White Paper

Critical Issues Related to Pressure Relief Devices In todays markets, equipment and components are often designed and manufactured in various global regions. The integration of such sub-systems may easily lead to unwanted misalignments with immediate impact on the hygienic aspect of the total system. Such correct-fit-issues are often considered minor when it comes to rigid process equipment such as valves and manifolds. For more sensitive devices, such as rupture/bursting discs, where the pressure sensitive membrane needs to be clamped directly into the ferrule in order to create a leak-tight, hygienic seal, the alignment issue becomes more critical. The improper combination of ferrules and rupture disc, can lead to sanitary misalignments. If the disc becomes damaged, there can be degrading effects with regards to the performance of these pressure safety devices. Improper alignment can also deteriorate the vacuum rating or the opening pressure of the rupture disc device. When there is doubt, the manufacturer should be consulted.

is required with regards to the European food safety regulations 1935/2004 and 2023/2006. This is to ensure that the components and equipment are in compliance with their intended use, without infringing on their safety performances. Summary In order to provide best performance and cleanability, the users and designers of sanitary installations must positively specify the intended ferrule connection for the piping system. It is essential to ascertain that all piping components and valves intended to be used are designed and certified for use in the specified ferrule connectors. In addition, all selected valves and fittings must be certified and marked for use in the specified ferrule. The satisfactory performance of critical pressure relief devices such as rupture discs can be expected where clamping arrangement specifications are aligned. By aligning the individual specifications, the clean processing and cleanability of the process piping and connections, will be as expected. References:
http://www.asme.org/products/codes---standards/bioprocessingequipment-(2) http://www.fda.gov/Food GuidanceComplianceRegulatoryInformation/ CurrentGoodManufacturingPracticesCGMPs/default.htm http://ec.europa.eu/health/documents/eudralex/vol-4/index_ en.htm http://www.who.int/medicines/areas/quality_safety/quality_ assurance/production/en/ http://ec.europa.eu/food/food/chemicalsafety/foodcontact/ framework_en.htm Roger Bours Pressure Relief Sales Manager Fike Europe Fike Europe B.v.b.a. Toekomstlaan 52 2200 Herentals Belgium Tel: +32-14-210031 Fax: +32-14-210743 www.fike.com
6

Clamping configuration of bursting disc device in ferrule type connection

To avoid these potential installation issues, safety authorities and users in some regional markets require that all such devices be marked and certified with appropriate and clear references to the holding device (ferrule standard) for which the subject part is certified. There is an emerging requirement to mark the relevant piping components such as the rupture discs with the type designation of the ferrule (ASME BPE, DIN 32676, ISO 2852) in which it is to be used. For use in the European Economic Area, a written compliance statement

Copyright 2012, Fike Corporation. All rights reserved. Form No. IPGWP-001A4 1012