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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:

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Introduction to Equipment Issues


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Presentation Transcript
slide2

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.
slide3

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.

slide4

Personnel

Standar-

dization

Procedure

Factors

contributing to

Product Quality

Raw

materials

Equipments

Packaging

materials

Building

Environment

FACTORS AFFECTING PRODUCT QUALITY

slide5

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.
slide6

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.
slide8

DESIGN & CONSTRUCTION (1)

  • Surfaces must not be:
    • Reactive
    • Additive
    • Adsorptive
slide9

DESIGN & CONSTRUCTION (2)

  • Easily & conveniently cleanable

Before cleaning

After cleaning

slide10

DESIGN & CONSTRUCTION (3)

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

slide11

DESIGN & CONSTRUCTION (4)

Must use explosion

proof materials for the

manufacture of

flammable substances

slide12

PIPES & PIPELINES (1)

Fixed pipelines for the transfer of products and materials should :

  • be clearly labelled
  • indicate contents
  • show direction of flow
slide13

PIPES & PIPELINES (2)

Water, steam, pressure and vacuum lines where applicable should be installed :

  • easily accessible
  • clearly identified
  • instrument monitoring control
slide14

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
slide15

SAFETY DEVICES

All safety and regulator devices should be checked and calibrated regularly

Air pressure regulator

Pressure gauge &

release valve

Control panel

slide16

LOCATION & INSTALLATION (1)

  • Avoid congestion.
  • Properly identified.
  • Easily accessible during all phases of operation.
slide17

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
slide18

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.
slide19

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.

slide20

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.

slide21

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.
slide22

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
slide23

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 date : ____

By : ______________

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.

CAL. ID. No.

_______________

CALIBRATION

VOID

IF BROKEN

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.

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.

CALIBRATION VOID

DO NOT USE

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.

NOT A CALIBRATION

INSTRUMENT

CALIBRATION LABELS

slide24

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.
slide25

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.
slide26

REFERENCES

  • ASEAN Guidelines for Cosmetic GMP (2003)
  • WHO EDM, Basic Principle of GMP: Equipment part 1 and 2 (2004)
  • Validationworld.com, Equipment Compliance Program Elements and Realization (2002).
  • Labcompliance.com, Equipment Validation & Qualification.
  • www.fda.gov., Equipment & Calibration
  • WHO, Good Manufacturing Requirements – Part 2: Validation (February 1997)
  • Barwa, N.S., GMP Equipment, Bandung, (October 2004)