1. Introduction to Equipment
Issues

2. 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.

3. 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.
Our objectives for the session are:
Firstly to look at the general requirements concerning equipment. What is important in a general sense? What are the reasons for selecting a certain type of equipment? Are there any important problems relating to certain types of equipment?
The second objective is to ensure that the equipments and apparatus used for manufacturing process are made with stable/proper material, correct design, safe and convenient to operate.
Then prepare in group session a list of the concerns that you have when inspecting factories. For example, you might include your own lack of knowledge of the operations of a particular type of machine or process.

4. FACTORS AFFECTING PRODUCT QUALITY
materials
Raw
Personnel
Procedure
Standar-
dization
Equipments
Building
Environment
Packaging
Factors
contributing to
Product Quality

5. BASIC PRINCIPLES Equipment must be : designed, constructed, located,
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.
Equipment must be :
designed,
constructed,
located,
adapted,
maintained,
to suit their intended use.
Our objectives for the session are:
Firstly to look at the general requirements concerning equipment. What is important in a general sense? What are the reasons for selecting a certain type of equipment? Are there any important problems relating to certain types of equipment?
The second objective is to ensure that the equipments and apparatus used for manufacturing process are made with stable/proper material, correct design, safe and convenient to operate.
Then prepare in group session a list of the concerns that you have when inspecting factories. For example, you might include your own lack of knowledge of the operations of a particular type of machine or process.

6. 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.
Basic requirement :
The selection, purchase, and installation of the most appropriate manufacturing equipment is important to successfully manufacture a cosmetic product to specifications.
After this manufacturing equipment has been installed and placed in operation.
It shall be maintained. This includes the periodic inspection, adjustment, cleaning, and other maintenance of this equipment to insure that product specifications continue to be met.
If the manufacturing equipment used in production includes computers or an automated data processing system, the manufacturer shall validate the software for its intended use and the software changes using an established protocol
In addition the manufacturer is responsible for ensuring the establishment of routine calibration, inspection, and maintenance on all of their inspection, measuring, and test equipment so this equipment will be suitable for its intended use

7. DETAIL DESCRIPTIONS

8. DESIGN & CONSTRUCTION (1)
Surfaces must not be:
Reactive
Additive
Adsorptive

9. DESIGN & CONSTRUCTION (2)
Easily & conveniently cleanable
Before cleaning
After cleaning

10. DESIGN & CONSTRUCTION (3)
3. Must not affect the product through leaking valves, inappropriate maintenance, etc.

11. DESIGN & CONSTRUCTION (4)
Must use explosion
proof materials for the
manufacture of
flammable substances

12. PIPES & PIPELINES (1)
Fixed pipelines for the transfer of products and materials should :
be clearly labelled
indicate contents
show direction of flow

13. PIPES & PIPELINES (2)
Water, steam, pressure and vacuum lines where applicable should be installed :
easily accessible
clearly identified
instrument monitoring control

14. 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

15. SAFETY DEVICES
All safety and regulator devices should be checked and calibrated regularly
Air pressure regulator
Pressure gauge &
release valve
Control panel

16. LOCATION & INSTALLATION (1)
Avoid congestion.
Properly identified.
Easily accessible during all phases of operation.

17. 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
Prevention of cross-contamination and error is of great importance to the factory's operations. Means the main target is there must be no possibility of cross-contamination.
Layout principle :
The layout, design and location of equipment can result in possible cross-contamination of products.
Inspectors should ask the company questions about the way in which equipment is cleaned to remove all of the materials from the previous batch. Another source of cross-contamination is dust.
Complex-designed equipment could also result in maintenance not being performed as recommended by the supplier of the equipment. Equipment must be maintained to ensure that it performs in the way that it is supposed to. The company should be able to show to you that it has maintenance schedules for major pieces of equipment and that it has people who are capable of maintaining the equipment. Alternatively, it should be able to show that it uses contract maintenance people who understand the equipment, and the use to which it is to be put.
The operation of the equipment must not lead to adverse quality problems developing unnoticed.

18. 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.

19. 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.

20. 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.

21. 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.
have a written schedule for performing these activities;
where adjustment is necessary to maintain proper operation, post the inherent limitations and allowable tolerances of the equipment or make these readily available to personnel responsible for making the adjustments;
document the maintenance activities including the date and individual(s) performing the maintenance activity and the date and individual(s) conducting the inspections;
have procedures for conducting periodic inspections to assure adherence to maintenance schedules; and,
audit the activities and document the inspection.

22. 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
The calibration program implemented by a company may be as simple, or as sophisticated as required for the measurements to be made.
Some instruments need only be checked to see that their performance is within specified limits, while others may require extensive calibration to a specification.
GMP calibration requirements are:
routine calibration according to written procedures;
documentation of the calibration of each piece of equipment requiring calibration;
specification of accuracy and precision limits;
training of calibration personnel;
use of standards traceable to the National Standards Institution, other recognizable standards, or when necessary, in-house standards; and provisions for remedial action to evaluate whether there was any adverse effect on the product's quality.
Remedial action includes recalibration and evaluation of the impact of out-of-tolerance measurements:
on the device design or process validation parameters or data;
on the quality of existing components, in-process, or finished products; and
appropriate corrective action.
A typical equipment calibration procedure includes:
purpose and scope;
frequency of calibration;
equipment and standards required;
limits for accuracy and precision;
preliminary examinations and operations;
calibration process description;
remedial action for product; and
documentation requirements.
Calibration Records
Calibration of each piece of equipment shall be documented to include:
equipment identification,
the calibration date,
the calibrator, and
the date the next calibration is due.

23. CALIBRATION LABELS _______________ Calibration date : ____
By : ______________
Due : ______________
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
CAL. ID. No.
_______________
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.
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.
Calibration information is entered onto cards or forms, one for each piece of equipment, or entered into a computerized data system.
Most data systems include the calibration date, by whom calibrated, date recalibration is due, the reason for the calibration, comments, address of the manufacturer and calibration laboratory, equipment specifications, serial number, use, etc.
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.

24. 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.
General principle of the change control program
The purpose of the Change Control Program is to ensure that facility, utility systems and equipment remain in state of compliance during whole validation life cycle.
The Change Control procedure outlines the steps to follow when a change is proposed for a critical system or process, and defines what changes are critical and non-critical.
Decision about necessity of re-calibration and its scope is based on discretion of the authorized personal and depend on the nature of changes, criticality of a component and how they impact on different aspects of production.

25. 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.
The training program:
Equally important to the purchasing and maintenance of manufacturing equipment is the adequate training of personnel so they are able to operate the equipment correctly.
This training shall be documented.
Included in adequate personnel training is the establishment and maintenance of requirements for health, cleanliness, personal practices, and clothing of employees when contact between these people and the product or the environment could reasonably be expected to adversely effect the finished product quality

26. 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.
Equipment & Calibration
WHO, Good Manufacturing Requirements – Part 2: Validation (February 1997)
Barwa, N.S., GMP Equipment, Bandung, (October 2004)
Definition
QC Overview
Scope
General Principles
Responsibility
Quality Control Laboratory
Specification Control
In-Process Quality Control
Laboratory Documentation and Retention
Starting Materials and Packaging
Receipt
Sampling
Testing
Control of Starting/Packaging Materials Acceptance
Control of Process Water Acceptance
Control of Finished Product Acceptance
Out of Specification Investigation
Laboratory Reagent
Environment Monitoring
Stability Study
Calibration
Sub-contracting of Test and Calibration
Reprocessing
Return
Reference