Transcript Introduction to Equipment Issues INTRODUCTION Each manufacturer should assure that production equipment and quality control measurement equipment, including mechanical, electronic, automated, chemical, or other equipment,

Introduction to Equipment
Issues
INTRODUCTION
Each manufacturer should assure that production
equipment and quality control measurement
equipment, including mechanical, electronic,
automated, chemical, or other equipment, are:
 suitable for the intended use in the design,
manufacture, and testing of components, inprocess devices and finished devices;
 capable of producing valid results;
 operated by trained employees; and
 properly calibrated versus a suitable standard.
OBJECTIVE
To ensure the equipment and
apparatus used for manufacturing
process that must be made with
stable and proper material, correct
design, safe and easy to operate.
FACTORS AFFECTING PRODUCT QUALITY
Personnel
Factors
contributing to
Product Quality
Environment
Building
BASIC PRINCIPLES
Equipment should be appropriate for its intended
purpose and be appropriately designed, located,
cleaned, maintained and correctly installed, to:
 prevent contamination of subsequent batches
of product using the same area or equipment.
 prevent contamination of personnel or the
environment;
 prevent contamination of product by personnel
or the equipment.
BASIC REQUIREMENTS

Each cosmetic manufacturer should develop, conduct, control,
and monitor production processes to ensure that the end product
conforms to its specifications.

All equipment used to manufacture a product shall be
appropriately designed, constructed, placed, and installed to
facilitate maintenance, adjustment, cleaning, and use.

The degree of maintenance on equipment and the frequency of
calibration of measuring equipment will depend upon the type of
equipment, frequency of use, and importance in the
manufacturing process.

Where deviations from product specifications could occur as the
result of malfunctioning of equipment(s), the manufacturer shall
establish and maintain process control procedures.
DETAIL DESCRIPTIONS
DESIGN & CONSTRUCTION (1)
• Surfaces must not
be:
 Reactive
 Additive
 Adsorptive
DESIGN & CONSTRUCTION (2)
• Easily & conveniently
cleanable
Before cleaning
After cleaning
DESIGN & CONSTRUCTION (3)
3. Must not affect the
product through
leaking valves,
inappropriate
maintenance, etc.
DESIGN & CONSTRUCTION (4)
Must use explosion
proof materials for the
manufacture of
flammable substances
PIPES & PIPELINES (1)
Fixed pipelines for the transfer of
products and materials should :
 be clearly labelled
 indicate contents
 show direction of flow


PIPES & PIPELINES (2)
Water, steam, pressure
and vacuum lines where
applicable should be
installed :
 easily accessible
 clearly identified
 instrument
monitoring control
PIPES & PIPELINES (3)
 The material quality and quantity that
uses piping system should be
monitored and checked periodically.
 Pipelines for hazardous gas and liquid
installation…
 should be clearly labeled
 and pipe connections should use
the right materials
SAFETY DEVICES
All safety and regulator devices should be
checked and calibrated regularly
Air pressure regulator
Pressure gauge &
release valve
Control panel
LOCATION & INSTALLATION (1)
1. Avoid congestion.
2. Properly identified.
3. Easily accessible during all
phases of operation.
LOCATION & INSTALLATION (2)
•
•
•
Equipment layout and design must aim:
– to minimize risks of error
– to permit effective cleaning
– to permit effective maintenance
And to avoid:
– cross-contamination
– dust and dirt build-up
– any adverse effect on the quality of products
Equipment must be installed to:
– minimize risks of error
– minimize risks of contamination
FLEXIBLE HOSES
 The transfer system of
liquid product may be
through flexible hoses
made of suitable material
and compatible with the
product used, cleaning
&, disinfecting agents
and steam.
 It should be clearly
identified.
TYPE OF MATERIALS USED (1)
Most of the pipelines should be
Stainless Steel 316L as it is
stable when in contact with the
materials, during hot sanitation &
disinfection.
TYPE OF MATERIALS USED (2)
Plastic pipelines may be cheaper in
cost than stainless steel but the
disadvantage of it is being unstable
with hot sanitation and surface may
not be perfectly smooth which poses
a risk for germ contamination.
MAINTENANCE SCHEDULE
A manufacturer should establish schedules to maintain,
clean, and adjust equipment used in the manufacture of
cosmetic products, where failure to do so could have an
adverse effect on the equipment's operation and hence
the product.
To maintain, clean, or adjust equipment, the manufacturer
should:
 have a written schedule;
 where adjustment is necessary to maintain proper
operation, have special instruction;
 document the maintenance activities;
 check periodically;
 audit the activities and document the inspection.
CALIBRATION
 The intent of the GMP calibration
requirements is to assure adequate and
continuous performance of measurement
equipment with respect to accuracy,
precision, etc.
 The equipment should be calibrated
according to written procedures that include
specific directions and limits for accuracy
and precision. All results should be
documented.
 Proper and periodic calibration will assure
that the selected equipment continues to
have the desired accuracy
CALIBRATION LABELS
Calibration date : ____
By : ______________
Due : ______________
CAL. ID. No.
_______________
CALIBRATION
VOID
IF BROKEN
Typical calibration decals have a write-on surface. A tough
paper or cloth stock and a pressure sensitive adhesive are
used for easy application and removal of decal.
“Due” is the blank for date when recalibration is due
Calibration Identification Number or its equivalent is usually
the minimum information that may be on the equipment. This
information allows the manufacturer to read by finding the
associated calibration record/card/file.
A seal or protective cover for exposed, recessed calibration
controls on instruments. The calibration control cannot be
adjusted without breaking the seal or removing the instrument
case.
CALIBRATION VOID
DO NOT USE
Measuring equipment that is not calibrated or otherwise
unsuitable for use should be placed in a quarantine area or
labeled with a “calibration void” decal.
NOT A CALIBRATION
INSTRUMENT
A decal to be applied to measurement or monitoring
instrument not intended to use in determining conformance to
product master record specifications with respect to testing,
manufacturing, environmental control, etc.
CHANGE CONTROL
 All Change Control cases for equipment could be classified in the
following five groups:
• Equipment Modification
• Equipment Relocation
• Equipment Status Changes
• Equipment Malfunctioning
• Calibration Failures
 Where intended changes are to be made, corrective actions must be
defined before their implementation for the first 3 groups. The other
two groups, which are unplanned cases, need to provide proper
documentation.
 If equipment has malfunctioned, and as a result of repair, some
critical components were replaced or readjusted, it should be
recalibrated immediately.
 Justification, necessary actions, and approval for all changes should
be documented on Corrective Action forms, which are designed as a
part of the Change Control SOP.
TRAINING PROGRAM
 The training program should be established
to assure that the personnel involved in
execution, operation, calibration and
preventive maintenance will understand and
follow up all written Standard Operating
Procedures and Equipment Work
Instruction.
 Training must be provided upon approval of
each SOP or WI for the personnel that will
be execute this particular procedure.
REFERENCES
1. ASEAN Guidelines for Cosmetic GMP (2003)
2. WHO EDM, Basic Principle of GMP: Equipment
part 1 and 2 (2004)
3. Validationworld.com, Equipment Compliance
Program Elements and Realization (2002).
4. Labcompliance.com, Equipment Validation &
Qualification.
5. www.fda.gov., Equipment & Calibration
6. WHO, Good Manufacturing Requirements – Part
2: Validation (February 1997)
7. Barwa, N.S., GMP Equipment, Bandung,
(October 2004)