N.A.

Health and Beauty Care Clean and Sanitary Design Guidelines

AREA: PIPING

Figure 1

TOPIC: CONNECTIONS

DESCRIPTION: Metal pipe is joined using a variety of methods including welds, bolted flanges, threads,
sanitary clamps (Figure 1), bevel seat ACME threaded, and other mechanical compression joints such as
unions, packed bell-and-spigot, etc. Due to the constraints of sanitary GMP design for piping systems, this
discussion will focus on the three most common mechanical pipe joints for sanitary systems: the sanitary
clamp fitting, the bevel seat ACME threaded fitting, and the bolted flange.

Option 1: Sanitary Clamp (S-clamp) Connection

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The sanitary S-clamp fittings (Figure 2) offer greater speed and ease of installation than other types of
connections. S-clamp fittings consist of a tapered ring welded onto the end of a pipe. The thickest
part of the taper is against the pipe. The face of the tapered ring has a machined groove for a fitted
gasket. A gasket is placed between two S-clamp fittings. A special, segmented, hinged clamp wraps
around the two tapered rings and gasket. A bolt on a screw is fitted to the slotted ends of the clamp
and tightened. This forces the two tapered rings and gasket to be clamped together. S-clamp fittings
also allow for quick disassembly for cleaning.

Figure 2

The S-clamp fitting is a machined and polished fitting which, coupled with its design, greatly reduces
the cracks and crevices found with other types of connections. An elastomer or polymer gasket forms
a precise fit between the S-clamp pipe ends. This prevents leakage of product and provides a smooth,
continuous surface inside the pipe.

REQUIREMENTS:

SANITIZABLE: Sanitizing involves maintaining the conditions for exposure time,

temperature, and frequency prescribed by manufacturing standards to ensure an adequate level
of microbial kill. Sanitizing can be done with hot USP water, steam, or sanitization chemicals,
as specified by the Site Microbiologist and/or sector QA. The preferred method of Sanitizing
is Sanitize-in-Place (SIP).

Minimum temperature and time must be met for heat sanitization. Minimum time and
concentration must be met for chemical sanitization. Consult the Site Microbiologist and/or
sector QA for these minimum required conditions. The piping connection material of
construction and finish must be able to withstand sanitizing agents and temperatures.
Option 1 Requirements (Continued):
CLEANABLE: Piping connections must be designed so that product can be easily removed
from product contact surfaces to prevent contamination of product by unwanted materials.
Cleanability is a function of design. In particular, it is a function of surface finish, material
compatibility, and the use of sanitary fittings. Finish for product contact surfaces must be at
least as smooth as 35 Ra. The material of construction must be compatible with the product
and with the cleaning and sanitizing agents to be used. The procedures for disassembly,
cleaning (both the parts removed and the parts remaining on the equipment), and reassembly
must be validated.

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The preferred method for cleaning is Clean-in-Place (CIP). CIP procedures must reduce
product residual and CIP cleaning agents to an acceptable level from the product contact
surfaces. In general, CIP cleaning agents must have a velocity of at least 3 to 5 feet per second
relative to the surface to be cleaned for the CIP procedure to be effective. The actual cleaning
velocity requirements must be validated. The piping connections material of construction must
be able to withstand the cleaning agents, temperatures, and conditions found during CIP. If the
piping connection is not CIP capable, then easy disassembly will be required for cleaning.

DRAINABLE: It is imperative the design of the piping connection allow for liquid and
product to be drained from the piping connection's surfaces, leaving behind as little residue as
possible. Any remaining liquid or product may act as a source for contamination and microbial
growth.

Most equipment will have product contact parts removable for cleaning and sanitizing. If
product contact parts do remain on the equipment during cleaning and sanitizing, then the
design must allow for liquid and residual product to be drained from the equipment,
minimizing residue. Note: Refer to the glossary for the definition of drainable.

DESIGN ISSUES:

1. For all equipment supports and installation requirements, see the Facilities section for clean design
guidelines.

2. The S-clamp pipe ends must be carefully aligned. Misaligned pipe cannot be pulled into place with
an S-clamp connection.

3. For Health and Beauty Care applications, it is extremely rare to require temperatures in excess of
250o F and pressures in excess of 150 psig. Standard tubing and pipe will readily withstand
these conditions. However, some of the quick opening (toggle clamp and wing nut) clamp
designs available are not rated for these conditions, particularly for the larger tubing sizes.
The design team will select the appropriate style of clamp to suit the required temperature
and pressure.

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Option 1 (Continued):
Design Issues (Continued):
4. It is important to minimize the use of S-clamp fittings. Use only at equipment and gauge
connections. Pipes should be welded at as many joints as possible.

5. Selection of appropriate gasketing is an important factor both in terms of integrity of the S-clamp
joints, and in assuring that the process stream is not chemically contaminated (by the
gasket material). The gasketing must be chemically compatible with the process fluid,
cleaning solution and sanitizing solution, at the operating temperatures of the respective
fluids. Also, the materials selected must be FDA approved. The design team will select
suitable gasket materials, based on plant experience or compatibility data.

6. Follow the 6-diameter pipe rule when connecting one pipe to another, or to a valve or piece of
equipment. 6-diameter rule: the dead leg (branch flow) length must be less than 6 times the
smaller of the two pipe diameters being connected.

REQUIRED RESOURCES:

Working with the Product Development and sector engineering resources, conduct a thorough
vendor capability evaluation.

Working with the Site Microbiologist and/or sector QA, determine: 1) the microbial
susceptibility for each product; 2) the requirements for sanitizing, cleaning, and draining and
how these will be accomplished.

The North American Health and Beauty Care Manufacturing Standards contain a Material of
Construction document specifying approved materials for specific processes or product
contact as per Product Development. Site QA and/or Product Development can help access
this document and can work to answer additional questions.

Option 2: Sanitary Bevel Seat Acme Threaded Connection

Figure 3

This type of sanitary fitting (Figure 3) is widely used in the dairy industry where a strong, high
pressure joint is required while meeting sanitary 3A standards.

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This joint is comprised of machined and mated beveled pipe ends similar to a standard pipe union
joint. The outside threads used to connect the joint are cut square in cross section rather than
triangular like a standard threaded fitting. A nut slides over the male beveled pipe end and connects to
the threaded female beveled seat.
Option 2 (Continued):

This fitting provides a very strong sanitary method for joining pipe to equipment or to other pipe
sections. It is a very accurately machined fitting which requires careful alignment of the pipe sections.
There is no gasket required with this fitting. The threaded sections can be quickly disassembled where
required for cleaning.

The bevel seat fitting is typically used without a gasket, and for lower pressures (near atmospheric).
For pressure applications, a gasket is required. In such cases a bevel seat is rated at 150 psig at 250F
for 3 size to 400 psig at 70F for 1-1/2 size. By comparison, these pressures are lower than for S-
clamp connections using double-bolted clamps.

REQUIREMENTS:

Refer to the Sanitizable, Cleanable, and Drainable Requirements for Sanitary Clamp Connection.

DESIGN ISSUES:

1. For all equipment supports and installation requirements, see the Facilities section for clean design
guidelines.

2. The ACME threaded fitting pipe ends must be carefully aligned. Misaligned pipe cannot be pulled
into place with an ACME threaded fitting connection.

3. Pressure requirements must be taken into consideration, since the ACME Threaded Fitting (bevel
seat) cannot withstand much pressure, particularly without use of a gasket. Alternative
pipe connections will be required for pressures above 40-50 psig.

4. Should a gasket be required, selection of appropriate gasketing is an important factor both in

terms of integrity of the seal, and in assuring that the process stream is not chemically
contaminated (by the gasket material). The gasketing must be chemically compatible with
the process fluid, cleaning solution and sanitizing solution, at the operating temperatures
of the respective fluids. Also, the materials selected must be FDA approved. The design
team will select suitable gasket materials, based on plant experience or compatibility data.

5. It is important to minimize the use of ACME threaded fittings. Use only at equipment and
instrument connections. Pipe should be welded at as many joints as possible.

6. Follow the 6-diameter pipe rule when connecting one pipe to another, or to a valve or piece of
equipment. 6-diameter rule: the dead leg (branch flow) length must be less than 6 times the
smaller of the two pipe diameters being connected.

REQUIRED RESOURCES:

Refer to Required Resources for Sanitary Clamp Connection.

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Option 3: Bolted Flange Connections

Flanged connections are one of the oldest, most reliable, most used connections in the process
industry. A flange connection consists of a flat, circular metal plate with a hole in the center. Pipe of
appropriate size is welded to the inside of the center hole. Bolt holes are located on a bolt circle
around the center hole. These are mated to the bolt holes of the connecting pipe flange. A gasket is
inserted between the flanges and bolts/nuts are used to tighten one flange to another.

The mating faces of flanges can be machined with grooved raised faces to provide a positive seating
of the gasket.

The bolted flange provides a very strong joint and can be rated up to several hundred psig.

By its very nature, a gasketed flange connection is not a sanitary design. The flanges are usually
machined or cast to very loose tolerances, relative to sanitary design tolerances. The gasket is cut
from a large sheet of material, often in the field. The mate-up of pipe sections is often not straight,
allowing for small crevices and gasket overlap that trap product. To effect good interior cleaning, to
the extent required for sanitary operation, disassembly will usually be required.

REQUIREMENTS:

Refer to the Sanitizable, Cleanable, and Drainable Requirements for Sanitary Clamp Connection .

DESIGN ISSUES:

1. For all equipment supports and installation requirements, see the Facilities section for clean design
guidelines.

2. If the stream is a raw material, it may not be susceptible to microbial contamination, thereby
allowing for use of flanged connections rather than sanitary type connections. However,
if sanitary design is desired, but precluded for some other reason (e.g., pressure is too
high), it is important to minimize the use of bolted flanges - use primarily at equipment and
instrument connections. Pipe should be welded at as many joints as possible.

3. Pressure and temperature requirements must be taken into consideration in selecting appropriately
rated flanges for the application.

4. Selection of appropriate gasketing is an important factor both in terms of integrity of the joint,
and in assuring that the process stream is not chemically contaminated (by the gasket
material). The gasketing must be chemically compatible with the process fluid, cleaning
solution, and sanitizing solution at the operating temperatures of the respective fluids. The
design team will select suitable gasket materials, based on plant experience or
compatibility data.

Option 3 (Continued):
Design Issues (Continued):

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5. Follow the 6-diameter pipe rule when connecting one pipe to another, or to a valve or piece
of equipment. 6-diameter rule: the dead leg (branch flow) length must be less than 6 times
the smaller of the two pipe diameters being connected.

REQUIRED RESOURCES:

Refer to Required Resources for Sanitary Clamp Connection.

Associated Topic: Gaskets

At pipe joints other than those which are butt-welded, or possibly for bevel seat connections, some
type of gasket must be used. Selection of appropriate gasketing material is an important factor both in
terms of joint integrity and in assuring that the process stream is not chemically contaminated. The
gasketing must be chemically compatible with process materials, cleaning solutions, process
temperatures, and sanitization times, temperatures, and solutions. All gasket materials must be FDA
approved for each application. It is recommended to test all new gasket materials for the above
requirements. The design team will select suitable gasket materials that meet all of the above
requirements.

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