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Guidance for Industry

SUPAC-SS: Nonsterile Semisolid

Dosage Forms

Manufacturing Equipment Addendum

DRAFT GUIDANCE

This guidance document is being distributed for comment purposes only.

Comments and suggestions regarding this draft document should be submitted within 60 days of

publication in the Federal Register of the notice announcing the availability of the draft guidance. 

Submit comments to Dockets Management Branch (HFA-305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the

docket number listed in the notice of availability that publishes in the Federal Register.

For questions on the content of the draft document contact Nancy Sager, 301-594-5633 (CDER).

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

December 1998

CMC #
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Guidance for Industry

SUPAC-SS: Nonsterile Semisolid

Dosage Forms

Manufacturing Equipment Addendum

Additional copies are available from:

the Drug Information Branch (HFD-210),

Center for Drug Evaluation and Research (CDER),

5600 Fishers Lane, Rockville, MD 20857, (Tel) 301-827-4573

Internet at http://www.fda.gov/cder/guidance/index.htm

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Drug Evaluation and Research (CDER)

December 1998

CMC xx
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TABLE OF CONTENTS

I. INTRODUCTION ................................................... . 1

II. PARTICLE SIZE REDUCTION/SEPARATION .......................... . 3

A. Definitions .................................................... . 3

B. Equipment Classifications ....................................... . 4

III. MIXING ........................................................... . 7

A. Definitions .................................................... . 7

B. Equipment Classification ........................................ . 8

IV. EMULSIFICATION ................................................ . 10

A. Definitions ................................................... . 10

B. Equipment Classification ....................................... . 10

V. DEAERATION .................................................... . 13

A. Definitions ................................................... . 13

B. Equipment Classification ....................................... . 13

VI. TRANSFER ....................................................... . 14

A. Definition ................................................... . 14

B. Equipment Classification ....................................... . 14

 VII. PACKAGING ..................................................... . 16

A. Definitions ................................................... . 16

B. Equipment Classification ....................................... . 16
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This guidance has been prepared under the auspices of the Chemistry, Manufacturing, and Controls 1

Coordinating Committee in the Center for Drug Evaluation and Research (CDER) and the Office of Regulatory Affairs

(ORA) at the Food and Drug Administration, with the assistance of the International Society of Pharmaceutical

Engineering (ISPE). This guidance represents the Agency's current thinking on equipment changes under SUPAC-SS. 

It does not create or confer any rights for or on any person and does not operate to bind the FDA or the public. An

alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations or

both.

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GUIDANCE FOR INDUSTRY 1

SUPAC-SS: Nonsterile Semisolid Dosage Forms

Manufacturing Equipment Addendum

I. INTRODUCTION

This guidance is intended to provide recommendations to pharmaceutical manufacturers using the

Center for Drug Evaluation and Research's guidance for industry, SUPAC-SS: Nonsterile

Semisolid Dosage Forms, Scale-Up and Post Approval Changes: Chemistry Manufacturing and

Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation (SUPAC-SS),

which published in June 1997. This document should be used in conjunction with the SUPAC-SS

guidance document in determining what documentation should be submitted to the Food and

Drug Administration (FDA) on equipment changes made in accordance with the

recommendations of the SUPAC-SS guidance document. The earlier SUPAC guidance document

defines (1) levels of change; (2) recommended chemistry, manufacturing, and controls tests for

each level of change; (3) recommended in vitro release tests and/or in vivo bioequivalence tests to

support each level of change; and (4) documentation that should support the change for new drug

applications (NDAs) and abbreviated new drug applications (ANDAs). 

This document is only an aid and, in some cases, specific equipment may not be listed. It does,

however, include a representative list of equipment commonly used in the industry. This guidance

does not address equipment that has been modified by a pharmaceutical manufacturer to fit its

specific needs. If questions arise in using this guidance, please contact the appropriate reviewing

office at CDER. 

Although this guidance does not discuss validation, any equipment changes should be validated in

accordance with current good manufacturing practices (CGMPs). The resulting data will be

subject to examination by field investigators during routine GMP inspections. The information

here is presented in broad categories of unit operation (particle size reduction and/or separation,

mixing, emulsification, deaeration, transfer, and packaging). Definitions and classifications are
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In the guidance for industry, SUPAC-SS Nonsterile Semisolid Dosage Forms, Scale-Up and Post Approval

2

Changes: Chemistry Manufacturing and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation

(SUPAC-SS), a changes being effected (CBE) supplement is recommended for a change in equipment to a "different design

or operating principle." On further review, CDER has determined this should state "different design and operating

principle." The SUPAC-SS guidance will be revised to make this change after the comment period closes on this Addendum

and it is finalized.

 Pub. L. 105-115 3

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provided. For each operation, a table categorizes equipment by class (operating principle) and

subclass (design characteristic). Examples are given within the subclasses.

Under SUPAC-SS, equipment within the same class and subclass are considered to have the same

design and operating principle. For example, a change from a planetary mixer from manufacturer

A to another planetary mixer from manufacturer B would not represent a change in design or

operating principle and would be considered the same.

A change from equipment in one class to equipment in a different class would usually be

considered a change in design and operating principle. For example, a change from a planetary

mixer to a dispersator mixer demonstrates a change in operating principle from low-shear

convection mixing to high-shear convection mixing. These types of equipment would be

considered different under SUPAC-SS.

Applicants should carefully consider and evaluate on a case-by-case basis changes in equipment

that are in the same class, but different subclasses. In many situations, these changes in 2

equipment would be considered similar. For example, in Section III, Mixing, under the

convection mixers, low shear, a change from an impeller mixer (subclass) to a planetary mixer

(subclass) represents a change within a class and between subclasses. Provided the manufacturing

process with the new equipment is validated, this change would likely not need a changes being

effected (CBE) supplement. At the time of such a change the applicant should have available the

scientific data and rationale used to make this determination. It is up to the applicant to determine

the filing category.

This guidance will be updated as needed to reflect the introduction and discontinuation of specific

types of manufacturing equipment. Manufacturers are encouraged to help keep the document

current by communicating changes to the Agency and by making suggestions on what equipment

should be put in the same class or subclass. The information submitted will be reviewed by FDA

and incorporated in an updated guidance document, as appropriate.

On November 21, 1997, the President signed the Food and Drug Administration Modernization

Act (FDAMA). Section 116 of FDAMA amended the Food, Drug, and Cosmetic Act by adding 3

section 506A (21 U.S.C. 356a), which provides requirements for making and reporting
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manufacturing changes to an approved human and animal drug application and for distributing a

drug product made with such change. The FDA is currently preparing a proposed rule to amend

its regulations (21 CFR 314.70 and 21 CFR 514.8) for supplements and other changes to

approved applications to implement the manufacturing changes provision of FDAMA. This draft

guidance will be revised as and when appropriate to take into consideration the revised

regulations in 21 CFR 314.70 and 21 CFR 514.8 when they are finalized.

II. PARTICLE SIZE REDUCTION/SEPARATION

A. Definitions

1. Unit Operations 

a. Particle Size Reduction: The mechanical process of breaking particles into

smaller pieces via one or more size reduction mechanisms. The mechanical

process used is generally referred to as milling. 

i. Particle - Either a discrete crystal or a grouping of crystals,

generally known as an agglomerate

ii. Particle Size Reduction Mechanisms

! Impact - Particle size reduction by applying an instantaneous force

perpendicular to the particle and/or agglomerate surface. The force

can result from particle-to-particle or particle-to-mill surface

collision.

! Attrition - Particle size reduction by applying force parallel to the

particle surface

! Compression - Particle size reduction by applying a force slowly (as

compared to impact) to the particle surface toward the center of the

particle

! Cutting - Particle size reduction by applying a shearing force to a

material

b. Particle Separation: Particle size classification according to particle size

alone

2. Operating Principles 
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a. Fluid Energy Milling: Particle size reduction by high-speed particle-toparticle impact and/or attrition (also known as micronizing)

b. Impact Milling: Particle size reduction by high-speed mechanical impact or

impact with other particles (also known as milling, pulverizing, or

comminuting)

c. Cutting: Particle size reduction by mechanical shearing

d. Compression Milling: Particle size reduction by compression stress and

shear between two surfaces

e. Screening: Particle size reduction by mechanically-induced attrition

through a screen (commonly referred to as milling or deagglomeration)

f. Tumble Milling: Particle size reduction by attrition, using grinding media

g. Separating: Particle segregation based on size alone, without any

significant particle size reduction (commonly referred to as screening or

bolting)

B. Equipment Classifications

1. Fluid Energy Mills 

Fluid energy mill subclasses have no moving parts and primarily differ in the

configuration and/or shape of their chambers, nozzles, and classifiers.

! Fixed target 

! Fluidized bed

! Loop and/or oval

! Moving target

! Opposed jet

! Opposed jet with dynamic classifier

! Tangential jet

2. Impact Mills 

Impact mill subclasses primarily differ in the configuration of the grinding heads,

chamber grinding liners (if any), and classifiers.

! Cage
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! Hammer air swept

! Hammer conventional

! Pin or disc

3. Cutting Mills

Although cutting mills can differ in whether the knives are movable or fixed, and in

classifier configuration, no cutting mill subclasses have been identified.

4. Compression Mills 

Although compression mills, also known as roller mills, can differ in whether one

or both surfaces move, no compression mill subclasses have been identified.

5. Screening Mills 

Screening mill subclasses primarily differ in the rotating element.

! Oscillating bar

! Rotating impeller

! Rotating screen

6. Tumbling Mills 

Tumbling mill subclasses primarily differ in the grinding media used and whether

the mill is vibrated.

! Ball media

! Rod media

! Vibrating

7. Separators 

Separator subclasses primarily differ in the mechanical means used to induce

particle movement.

! Centrifugal

! Vibratory or shaker

Note: If a single piece of equipment is capable of performing multiple discrete unit operations, it

has been evaluated solely for its ability to impact particle size or separation.
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 Table 1 Unit Operation - Particle Size Reduction

Class Subclass Examples

Fluid Energy Mills Fixed Target None Identified

Fluidized Bed None Identified

Loop/Oval Fluid Energy Aljet

Moving Target None Identified

Opposed Jet Garlock

Opposed Jet with Dynamic Alpine (Hosokawa)

Classifier Fluid Energy Aljet

Tangential Jet Alpine (Hosokawa)

Fluid Energy Aljet

Sturtevant

Impact Mills Cage Stedman

Hammer Air Swept Alpine (Hosokawa)

Bepex (Hosowaka)

Sturtevant

Hammer Conventional Alpine (Hosokawa)

Fitzpatrick

Fluid Air

Mikro (Hosokawa)

Rietz (Hosokawa)

Stokes-Merrill

Pin/Disc Alpine (Hosokawa)

Kemutec

Sturtevant

Cutting Mills None Identified Alpine (Hosokawa)

Fitzpatrick

Urschel

Compression Mills None Identified MCA International

Ross

Stokes-Merrill

Screening Mills Oscillating Bar Bepex (Hosokawa)

Frewitt

Jackson-Crockatt

Stokes-Merrill

Vector

Rotating Impeller Bepex (Hosokawa)

Fitzpatrick

Fluid Air

Kemutec

Quadro

Stokes-Merrill

Zanchetta (Romaco)

Rotating Screen Glatt

Tumbling Mills Ball Media US Stoneware

Rod Media None Identified

Vibrating Sweco
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Table 2 Unit Operation - Separation

Class Subclass Examples

Separators Centrifugal AZO

Kason

Kemutec

Sweco

Vibratory/Shaker Allgaier

McLanahan

Rotex

Russell Finex

Sweco

Vortisiv

III. MIXING

A. Definitions

1. Unit Operation

Mixing: The reorientation of particles relative to one another to achieve

uniformity or randomness. This process can include wetting of solids by a liquid

phase, dispersion of discrete particles, or deagglomeration into a continuous phase. 

Heating and cooling via indirect conduction may be used in this operation to

facilitate phase mixing or stabilization.

2. Operating Principles

a. Convection Mixing, Low Shear: Mixing process with a repeated pattern of

cycling material from top to bottom, in which dispersion occurs under low

power per unit mass through rotating low shear forces

b. Convection Mixing, High Shear: Mixing process with a repeated pattern of

cycling material from top to bottom, in which dispersion occurs under high

power per unit mass through rotating high shear forces

c. Roller Mixing (Milling): Mixing process by high mechanical shearing

action where compression stress is achieved by passing material between a

series of rotating rolls. This is commonly referred to as compression or

roller milling.

d. Static Mixing: Mixing process in which material passes through a tube
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with stationary baffles. The mixer is generally used in conjunction with an

in-line pump.

B. Equipment Classification

1. Convection Mixers, Low Shear

This group normally operates under low shear conditions and is broken down by

impeller design and movement. Design can also include a jacketed vessel to

facilitate heat transfer.

! Anchor or sweepgate

! Impeller

! Planetary

2. Convection Mixers, High Shear

This group normally operates only under high shear conditions. Subclasses are

differentiated by how the high shear is introduced into the material, such as by a

dispersator with serrated blades or homogenizer with rotor stator.

! Dispersator

! Rotor stator

3. Roller Mixers (Mills)

No roller mixer subclasses have been identified.

4. Static Mixers

No static mixer subclasses have been identified.

Note: If a single piece of equipment is capable of performing multiple discrete unit operations, it

has been evaluated solely for its ability to mix materials.
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Table 3 Unit Operation - Mixing

Class Subclass Examples

Convection Mixers, Brogli

Low Shear

Anchor/Sweepgate

Fryma

GEI Krieger (GEI North America)

Groen

Koruma (Romaco)

Lee Industries

Ross

Waukesha Cherry Burrell

Impeller Bematek

Chemineer

Gate

IKA

Lightnin

Moorhouse-Cowles

Quadro

Ross

Planetary Aaron

Aeschbach

AMF

GEI-Collette (GEI North America/Vector)

Hobart

Jaygo

Littleford Day

Ross

Vrieco

Convection Mixers, Chemineer

High Shear

Dispersator

Cowles

Gate

IKA

Koruma (Romaco)

Lightnin

Ross

Roto Stator Arde-Barinco

Bematek

Fryma

Gaulin

Greerco

Koruma (Romaco)

Manton Gaulin

Moorhouse-Cowles

Premier

Ross

Silverson

Tri-Homo

Ultra Turex

Urschel
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Table 3 Unit Operation - Mixing (cont.)

Class Subclass Examples

Roller Mixers (Mills) None Identified MCA International

Ross

Stokes Merrill

Static Mixers None Identified Ross

IV. EMULSIFICATION

A. Definitions

1. Unit Operation

Emulsification: The application of physical energy to a liquid system consisting of

at least two immiscible phases, causing one phase to be dispersed into the other.

2. Operating Principles

a. Low Shear Emulsification: Use of low shear energy using mechanical

mixing with an impeller to achieve a dispersion of the mixture. The

effectiveness of this operation is especially dependent on proper

formulation.

b. High Shear Emulsification: Use of high shear energy to achieve a

dispersion of the immiscible phases. High shear can be achieved by the

following means:

i. Stirring the mixture with a high speed chopper or saw-tooth

dispersator

ii. Passing the mixture through the gap between a high-speed rotor

and a stationary stator

iii. Passing the mixture through a small orifice at high pressure (valvetype homogenizer) or through a small orifice at high pressure

followed by impact against a hard surface or opposing stream

(valve-impactor type homogenizer), causing sudden changes of

pressure

B. Equipment Classification
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1. Low Shear Emulsifiers

Although low shear emulsification equipment (mechanical stirrers or impellers) can

differ in the type of fluid flow imparted to the mixture (axial-flow propeller or

radial-flow turbines), no subclasses have been defined.

2. High Shear Emulsifiers

Subclasses of high shear emulsification equipment differ in the method used to

generate high shear.

! Dispersator

! Rotor stator

! Valve or pressure homogenizer

Note: If a single piece of equipment is capable of performing multiple discrete unit operations,

the unit has been evaluated solely for its ability to emulsify materials.
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Table 4 Unit Operation - Emulsification

Class Subclass Examples

Low Shear Emulsifiers None Identified Bematek

Lightnin

Moorhouse-Cowles

Ross

High Shear Emulsifiers Dispersator Chemineer

Cowles

Gate

IKA

Koruma (Romaco)

Lightnin

Ross

Rotor Stator Arde-Barinco

Bematek

Fryma

Gaulin

Greerco

Koruma (Romaco)

Manton Gaulin

Moorhouse-Cowles

Premier

Ross

Silverson

Tri-Homo

Ultra Turex

Urschel

Valve or Pressure

Homogenizer

Manton Gaulin

Microfluidics
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V. DEAERATION

A. Definitions

1. Unit Operation

Deaeration: The elimination of trapped gases to provide more accurate 

volumetric measurements and remove potentially reactive gases

2. Operating Principles

The use of vacuum or negative pressure, alone or in combination with mechanical

intervention or assistance

B. Equipment Classification

1. Deaerators

Deaerator subclasses differ primarily in their air removal paths, either through the

bulk material or through a thin film, and in whether they use a batch or in-line

process.

! Off-Line or in-line

! Vacuum vessel

Note: If a single piece of equipment is capable of performing multiple discrete unit operations, it

has been evaluated solely for its ability to deaerate materials.

Table 5 Unit of Operation - Deaeration

Class Subclass Examples

Deaerators Off Line/In Line Cornell Machine Co.

Fryma

Jaygo

Koruma (Romaco)

Vacuum Vessel Fryma

GEI-Kreiger (GEI North America)

Groen

Koruma (Romaco)

Lee Industries

Paul Mueller Co.
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VI. TRANSFER

A. Definition

1. Unit Operation

Transfer: The controlled movement or transfer of materials from one location to

another

2. Operating Principles

a. Passive: The movement of materials across a non-mechanically-induced

pressure gradient, usually through conduit or pipe

b. Active: The movement of materials across a mechanically-induced

pressure gradient, usually through conduit or pipe

B. Equipment Classification

1. Low Shear

Active or passive material transfer, with a low degree of induced shear

! Diaphragm

! Gravity

! Peristaltic

! Piston

! Pneumatic

! Rotating lobe

! Screw or helical screw

2. High Shear 

Active or mechanical material transfer with a high degree of induced shear

! Centrifugal or turbine

! Piston

! Rotating gear

Note: This section is intended to deal with the transfer of shear sensitive materials, including

product or partially manufactured product. A single piece of equipment can be placed in either a

low or high shear class, depending on its operating parameters. If a single piece of equipment is

capable of performing multiple discrete unit operations, the unit has been evaluated solely for its

ability to transfer materials.
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Table 6 Unit Operation - Transfer

Class Subclass Examples

Low Shear Diaphragm APV

Pulsafeeder

TL Systems

Tri-Clover

Wilden

Gravity None Identified

Peristaltic Barnant Co

Cole Palmer

Pulsafeeder

Vanton

Watson-Marlow

Piston APV

Graco

National

Nordson

Waukesha

Wilden

Pneumatic None Identified

Rotating Lobe Flowteck

Fristam

Sine

Tri-Clover

Viking 

Waukesha

Screw or Helical Screw Moyno

High Shear Centrifugal or Turbine APV

BMS

Fristam

Pulsafeeder

Tri-Clover

Vanton

Waukesha

Piston APV

Graco

National Instrument

Nordson

Waukesha

Wilden

Rotating Gear APV

BSM

Ertel Engineering

Pulsafeeder

Viking

Waukesha
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VII. PACKAGING

A. Definitions

1. Unit Operation

a. Holding: The process of storing product after completion of

manufacturing process and prior to filling final primary packs

. b. Transfer: The process of relocating bulk finished product from holding to

filling equipment using pipe, hose, pumps and/or other associated

components

c. Filling: The delivery of target weight or volume of bulk finished product to

primary pack containers

d. Sealing: A device or process for closing and/or sealing primary pack

containers following the filling process

2. Operating Principles

a. Holding: The storage of liquid, semi-solids, or product materials in a

vessel that may or may not have temperature control and/or agitation

b. Transfer: The controlled movement or transfer of materials from one

location to another

c. Filling: Filling operating principles involve several associated

subprinciples. The primary package can be precleaned to remove

particulates or other materials by the use of ionized air, vacuum, or

inversion. A holding vessel equipped with an auger, gravity, or pressure

material feeding system should be used. The vessel may or may not be able

to control temperature and/or agitation. Actual filling of the dosage form

into primary containers can involve a metering system based on an auger,

gear, orifice, peristaltic, or piston pump. A head-space blanketing system

can also be used.

d. Sealing: Primary packages can be sealed using a variety of methods,

including conducted heat and electromagnetic (induction or microwave) or

mechanical manipulation (crimping or torquing).

B. Equipment Classification
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1. Holders

Although holding vessels can differ in their geometry and ability to control

temperature or agitation, their primary differences are based on how materials are

fed.

! Auger

! Gravity

! Pneumatic (nitrogen, air, etc.)

2. Fillers

The primary differences in filling equipment are based on how materials are

metered.

! Auger

! Gear pump

! Orifice

! Peristaltic pump

! Piston

3. Sealers

The differences in primary container sealing are based on how energy is transferred

or applied.

! Heat

! Induction

! Microwave

! Mechanical or crimping

! Torque
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Table 7 Unit Operation - Holding

Class Subclass Examples

Holders Auger Bonafacci

Bosch

Cozzoli Machine

Erweka

Fryma-Maschinenbau

Inova 

Loeb Equipment

Sarong

Young Industries

Gravity Bonafacci

Bosch

Cozzoli Machine

Erweka

Fryma-Maschinenbau

Inova 

Loeb Equipment

Sarong

Young Industries

Pneumatic

(nitrogen, air, etc.)

Bonafacci

Bosch

Cozzoli Machine

Erweka

Fryma-Maschinenbau

Inova 

Loeb Equipment

Sarong

Young Industries
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Table 8 Unit Operation - Filling

Class Subclass Examples

Fillers Auger Bonafacci

Bosch

Erweka

Fryma-Maschinenbau

IWKA

Kalish

Norden

Sarong

Gear pump APV

BMS

Bonafacci

Bosch

Ertel Engineering

Erweka

Fryma-Maschinenbau

IWKA

Kalish

Norden

Pulsafeeder

Sarong

Viking

Waukesha

Orifice Bonafacci

Bosch

Erweka

Fryma-Maschinenbau

IWKA

Kalish

Norden

Sarong

Peristaltic pump Barnant Co.

Bonafacci

Bosch

Cole-Parmer

Erweka

Fryma-Maschinenbau

IWKA

Kalish

Norden

Pulsafeeder

Sarong

Vanton

Watson-Marlow
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Table 8 Unit Operation - Filling (cont.)

Class Subclass Examples

Fillers (cont..) Piston APV

Bonafacci

Bosch

Erweka

Fryma-Maschinenbau

Graco

IWKA

Kalish

National

Norden

Sarong

Waukesha

Wilden

Table 9 Unit Operation - Sealing

Class Subclass Examples

Sealers Heat Harro Höfliger Packaging

Hutchins and Hutchins

Loeb Equipment

Prodo-Pak

Romaco

VWR Scientific Products

Induction Pillar

Microwave None Identified

Mechanical/Crimping Austin Reed

Bishop International

Chase-Logeman

Cozzoli Machine

Integrated Packaging System

Loeb Equipment

Romaco

VWR Scientific Products

Torque Bausch and Stroebel Machine

Cozzoli Machine

Electronic Liquid Filler

Madison Equipment

Sure Torque