PHARMACEUTICAL EQUIPMENT

CONTENT :- Definition. Introduction. Design. Size. Location. Construction. Equipment identification. Equipment log. Cleaning & maintenance of equipment. Planned preventive maintenance progrmme. Validation of equipment. References.

EQUIPMENT Definition:- Any piece of plant, machinery, instrument etc. which is used for carrying out a specific activity or operation.

INTRODUCTION All the mfg. or control activities depends on good performance of equipment. Equipment shall be located, constructed & maintained to suit the operation to be carried out. Design & layout should minimizes the risk of error & permit effective cleaning & maintenance to avoid cross contamination.

Contd.... The equipment that come into contact with the product should not be reactive, additive or adsorptive. To avoid accidental contamination whenever possible non toxic edible grade lubricant shall be suitable.

DESIGN User Requirement Specification (URS). It should ans. the following questions What operation. What capacity. Which material. Cleaning. Do you have the trained operator. Starting & stopping time. Will maintenance cause any contamination of the product. What is the level of tech. used.

SIZE Based on the volume of material. It depends on Physical dimension of machinery (length× height× width). Size of room in which machine is going to be installed. Path in the plant through which it will be transported. Holding & output capacity. What is the minimum & maximum volume of material we are going to handle.

LOCATION 2. Potential danger of contamination & mix-up. Factors which influence location of equipment- 1. Logical process movement. 2. Potential danger of contamination & mix-up. 3. Utility service requirement. 4. Material handling & movement. 5. Movement for processing & cleaning. 6. Men movement for repair & maintenance.

CONSTRUCTION Ease of cleaning the equipment & surrounding area. Ease of operation of equipment. Ease of maintenance of equipment. Material of construction should be such that, 1. Do not react with product. 2. Should not absorb any material or part of it.

MATERIAL OF CONSTRUCTION METALS NON-METALS FERROUS NON-FERROUS IN -ORGANIC ORGANIC CAST IRON ALUMINIUM GLASS RUBBER STEEL CARBON LEAD PLASTICS STAINLESS S TEEL

MATERIAL OF CONSTRUCTION Quality of equipment depends on quality of MOC. Stainless steel preferred having different alloys such as, Austenitic stainless steel contents - 18% - chromium. 8% - nickel. non-magnetic and non – hardenable.

Stainless steel:- 304 Stainless steel: – 316 12% - nickel , 18% - chromium, 8 % - nickel, 2%- molybdenum. Stainless steel: – 316 12% - nickel , 6% - chromium, 2-3% - molybdenum.

contd... Chromium and nickel for steel corrosion resistant. Stainless steel is stabilized by titanium or tantalum. Minor amount copper, molybdenum and selenium. E.g.:-punches & dies.

OHNS punches & HCHC dies – 4 million tab. contd… The life of punches & dies depends upon their material of construction. OHNS punches & HCHC dies – 4 million tab. HCHC punches & HCHC dies – 7.5 million tab. Complete hard chrome plating punches & HCHC dies – 8.5 million tab.

PROPERTIES OF STAINLESS STEEL Heat resistant. Corrosion resistant. Ease of fabrication. Tensile strength. Cleaning and sterilization.

EQUIPMENT IDENTIFICATION According to U.S.F.D.A. guidelines, Every equipment having its own identification , drug product identified & which includes, 1. Name of product. 2. Batch number. 3. Batch size. 4. Processing stage. 5. Date & sign of production supervisor.

EQUIPMENT LOG The manufacturers must maintain a register or log. This log should be for operation, cleaning & maintenance. It contains, 1. Sr. No. 2. Name of equip. & distinctive identification no. 3. Product/ B. Nos. handled. 4. Date & time of operation ,cleaning & maintenance. 5. Name of operators & supervisors.

CLEANING OF EQUIPMENT For achieving identity, safety, strength & purity of product. For this you should have sop’s. Cleaning after use & must be checked for cleanliness before use Name and no. Responsible person, schedule, method. Material used for cleaning. previous batch inspection. Records.

Level of cleaning may be categorized as, contd… Level of cleaning may be categorized as, 1.Changeover from one batch to another of same product. E.g. Venlafaxine Actavis 75 mg (Y09998). Venlafaxine Actavis 75 mg (Y09999).

Contd.. 2.Changeover from one product to another. Eg. Venlafaxine Actavis 75 mg. Meloxicam Actavis 75 mg.

MAINTENANCE OF EQUIPMENT There are two types of maintenance Preventive maintenance: maintenance before any breakdown of machinery which prevents the machine breakdown. Breakdown maintenance: Maintenance work done after stopping machine due to problems.

DAILY MAINTENANCE RECORD SHEET Sr. No. Department Work performed Starting time Completion time Part replaced

AUTOMATIC,MECHANICAL AND ELECTRONIC EQUIPMENT Validation of computer system. To confirm the performance of that system with respect to its consistency repeatability accuracy. e.g. Auto sampler in dissolution apparatus.

PLANNED PREVENTIVE MAINTENANCE PROGRAMME [PPMP] Prepared by maintenance dept. Production dept. QC dept. Equipment preventive maintenance log which include Preventive maintenance done on. Preventive maintenance due on. Preventive maintenance done by.

VALIDATION OF EQUIPMENT URS- User requirement specification. DQ- Design Qualification. FAT- Factory acceptance test. SAT- Site acceptance test. IQ- Installation qualification. OQ- Operational qualification. PQ- Performance qualification.

URS It Includes:- Size of equipment. Speed of equipment. Expectations regarding equipment given by users called as URS. It Includes:- Size of equipment. Speed of equipment. Effectiveness of equipment.

Availability spares, change parts. Low dust & sound generation. MOC. contd.... Availability spares, change parts. Low dust & sound generation. MOC. Auto control systems. Easy change over. Lesser breakdowns. Overall good construction.

DESIGN QUALIFICATION Prepared by involving Departments like Engineering R & D User QA QC Maintenance Production

contd.. Easy to clean & maintain. Will not allow substances like lubricants, coolants in contact with any in-process material. Temp, pressure measuring devices should be located at easily accessible location. Non-reactive with finished or non finished product. Explosion free electrical parts.

FAT(Factory Acceptance Test) Inspection before to delivery to the user site –FAT During this user should test Every component of machine for the operation and functioning. Drawing of machine. Calibration. Other qualification and MOC certificates. Safety controls. Signal and critical control points.

SAT(Site Acceptance Test) The equipment at the user site for any change, damage & shipping before installation of machine.

Contd..... Component unpacking. Inspection & storage. Installation & power up. Installation of instrument. Instrument recalibration. Functional testing etc.

INSTALLATION QUALIFICATION “It is documented verification that all key aspects of the installation adhere to manufacturer’s recommendation, appropriate codes & approved design qualification”. E.g. Dissolution apparatus For apparatus:- 1 Vessel cylinder height :- 160-210mm Inner diameter:- 98-106 mm Capacity:- 1000 ml.

OPERATIONAL QUALIFICATION “Documented verification that the system or subsystem performs as intended throughout all specified operating range”. The system must be powered up & checked to ensure it is functioning correctly. e.g. computer system.

PERFORMANCE QUALIFICATION PQ is synonymous with OQ to some extent. OQ is performance of system. - without load. PQ is performance of system. - with load.

REFERENCES Prof. Manohar A. Potdar, Pharmaceutical Quality Assurance, Nirali Prakashan, first edition, July 2006, pg.no. 3.1, 8.14. United State Pharmacopoeia Convention, Inc. USP 26 Rockville, Maryland :US Pharmacopoeial convention, Inc. 2003. cGMP guide forum, cGMP4 guide forum and ISPE 2003. www.palm.com

Thank you Any Que.?