LIST OF EQUIPMENTS (AS PER SCHEDULE M)

WHAT IS SCHEDULE "M"......???

• Schedule M is a part of Drug and Cosmetic act 1940. It is GMP for pharmaceuticals that should he followed by pharmaceutical manufacturing units in India.
• It is a part of a quality assurance which ensures that the products are consistently manufactured and controlled to the Quality standards appropriate to their intended use.
• GMP-A set of principles and procedures which, when followed by manufacturers for therapeutic goods, helps ensure that the products manufactured will have the required quality.

LIST OF EQUIPMENTS (AS PER SCHEDULE M)

The following equipments are recommended:

(a) Manufacturing Area:

• Storage equipment for ampoules, vials, bottles and closures.
• Washing and drying equipment.Dust proof storage cabinet.
• Water still.Mixing and preparation tanks or other containers. 
• Mixing equipment where necessary.Filtering equipment.
• Hot air sterilizer. 

(b) Aseptic Fillin:g and Sealing Rooms:

• Benches for filling and sealing.
• Bacteriological filters.
• Filling and sealing unit under laminar flow workstation

(c) General Room:

• Leak testing table. 
• Labeling and packing benches. 
• Inspection table.

(d) Equipments:

1. Sterile Garment Cabinet:

• Made up of stainless steel. 
• Ensure a clean storage space by making use of UV disinfectant and heating through IR lamps.
• These cabinets may be designed in horizontal air flow system and clean air through HEPA filters.

2. Syringe Filling Machine:  

Characteristics:

• Barrier isolators.
• In-process check weighing Filling: rotary piston pumps.
• Volume: 0.2 to 29 ml.
• All types of syringes including glass,plastic can be filled.
• Filling Rate: 300 to 600 syringes in a minute.

3. Ampoule Washing Machine: Process:

• Water is sprayed onto the arnpoules. 
• Lurned to an angle of 180 degree with their mouth downward to remove water.
• Finally the ampoules are filled with compressed air to remove residual water. 
• Certain machines have a high temperature zone meant for killing any bacteria.

4. Vial Filling Machine: 

It is used to fill vials and bottles.It is used for Liquids, viscous material and suspensions and powders.                                    

Process:

• The machine comprises of an intake section which loads the vials.
• Transferred through an intermittent transport section. 
• Liquid filling section which fills the vials with predetermined quantity. 
• Finally the filled and rubber stoppered vials are released and discharged.