Module 4

1
ASEAN GMP TRAINING MODULEEQUIPMENT

• Prepared by
• Surachai Piyayodilokchai - Thailand
• Approved by
• ASEAN Cosmetic GMP Team
• Endorsed by
• ASEAN Cosmetic Committee

2
CONTENT OF PRESENTATION

• Introduction
• Objective
• Scope
• General requirements
• Basic principles
• Basic requirements
• The detail descriptions
• Design and construction
• Pipes and pipelines
• Safety devices
• Location Installation
• Maintenance program
• Equipment compliance records
• Training program
• References

3
INTRODUCTION
4
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,
  in-process devices and finished devices
• capable of producing valid results
• operated by trained employees and
• properly calibrated versus a suitable standard.

5
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.

6
SCOPE

• This module addresses the steps necessary to
  ensure that manufacturing equipment and
  laboratory apparatus continuously operates within
  the parameters necessary to produce a product
  that meets specifications.

7
GENERAL REQUIREMENTS
8
FACTORS AFFECTING PRODUCT QUALITY
9
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.

10
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.

11
DETAIL DESCRIPTIONS
12
DESIGN CONSTRUCTION (1)

• Surfaces must not be
• Reactive
• Additive
• Adsorptive

13
DESIGN CONSTRUCTION (2)

• Easily conveniently cleanable

Before cleaning
After cleaning
14
DESIGN CONSTRUCTION (3)

• 3. Must not affect the product through leaking
  valves, inappropriate maintenance, etc.

15
DESIGN CONSTRUCTION (4)

• Must use explosion proof materials for the
  manufacture of flammable substances.

16
PIPES PIPELINES (1)

• Fixed pipelines for the transfer of products and
  materials should
• be clearly labelled
• indicate contents
• show direction of flow

17
PIPES PIPELINES (2)

• Water, steam, pressure and vacuum lines where
  applicable should be installed
• easily accessible
• clearly identified
• instrument monitoring control

18
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

19
SAFETY DEVICES
All safety and regulator devices should be
checked and calibrated regularly
Air pressure regulator
Pressure gauge release valve
Control panel
20
LOCATION INSTALLATION (1)

1. Avoid congestion.
2. Properly identified.
3. Easily accessible during all phases of operation.

21
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

22
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.

23
TYPE OF MATERIALS USED (1)

• Most of the pipelines should be used with
  Stainless Steel 316L as it is stable when in
  contact with the materials, during hot
  sanitation disinfection.

24
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.

25
CLEANING EQUIPMENT (1)
Clean In Place
26
CLEANING EQUIPMENT (2)
Cleaning in Process
Cleaning protocol for trace back record
Cleaning status of the equipment should be
indicated on the label
27
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.

28
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

29
CALIBRATION LABELS
30
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.

31
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.

32
RELATED HYPERLINK DOCUMENTS

• Text of equipment of ASEAN GMP
• Sanitation of equipment
• Checklist for equipment audit
• Guidance for qualification performance

33
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)

34
Thank You