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Sterile products

Sterile products. Parenteral. Parenteral refers injectable route of administration. It derived from Greek words Para (Outside) and enteron (Intestine). So it is a route of administration other than the oral route. This route of administration bypasses the alimentary canal.

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Sterile products

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  1. Sterile products

  2. Parenteral Parenteral refers injectable route of administration. It derived from Greek words Para (Outside) and enteron (Intestine). So it is a route of administration other than the oral route. This route of administration bypasses the alimentary canal

  3. PRIMARY PARENTERAL ROUTES

  4. A. Containers: 1. Glass: • Highly Resistant Borosilicate Glass • Treated Soda lime Glass • Regular Soda Lime Glass • N.P (Non-parenteral) Glass Type 4 is not used for parenteral packaging, others all are used for parenteral packaging.

  5. 2. Plastic: Plastic containers are used but they face following problems • Permeation • Sorption • Leaching • Softening 3. Rubber: To provide closure for multiple dose vials, IV fluid bottles, plugs for disposable syringes and bulbs for ophthalmic pipettes, rubber is the material of choice. Problems associated with rubber closures are • Incompatibility • Chemical instability • Physical instability

  6. Intravenous Admixture System • “Admixture system” refers to sterile IV solutions that are prepared by using one or more medications or electrolytes and will be administered via the parenteral route. • It requires the measured addition of a medication to a 50 ml or larger bag or bottle of IV fluid. • It can be provided to the patient in his/her home. • Many hospitals involved in compounding IV solutions and medications to patient.

  7. PROCESSING OFPARENTERALS

  8. Formulation of parenteral products • In the preparation of parenteral products, the following substances are added to make a stable preparation: • The active drug • Vehicles • Aqueous vehicle (e.g. water for injection, water for injection free from CO2 ) • Non-aqueous vehicle (e.g. Ethyl alcohol, propylene glycol, almond oil) • Adjuvants • Solubilizing agents (e.g. Tweens & polysorbates) • Stabilizers & antioxidants (e.g. thiourea, ascorbic acid, tocopherol) • Buffering agents (e.g. citric acid, sodium citrate) • Antibacterial agents (e.g. benzyl alcohol, metacresol, phenol) • Chelating agents (e.g. EDTA) • Suspending, emulsifying & wetting agents (e.g. MC, CMC) • Tonicity factor (e.g. sodium chloride, dextrose)

  9. Production facilities of parenterals • The production area where the parenteral preparation are manufactured can be divided into five sections: • Clean-up area • Preparation area • Aseptic area • Quarantine area • Finishing & packaging area

  10. Clean-up area: • It is not aseptic area. • All the parenteral products must be free from foreign particles & microorganism. • Clean-up area should be withstand moisture, dust & detergent. • This area should be kept clean so that contaminants may not be carried out into aseptic area. • Preparation area: • In this area the ingredients of the parenteral preparation are mixed & preparation is made for filling operation. • It is not essentially aseptic area but strict precautions are required to prevent any contamination from outside.

  11. Aseptic area: • The parenteral preparations are filtered, filled into final container & sealed should be in aseptic area. • The entry of personnel into aseptic area should be limited & through an air lock. • Ceiling, wall & floor of that area should be sealed & painted. • The air in the aseptic area should be free from fibers, dust and microorganism. • The High efficiency particulate air filters (HEPA) is used for air. • UV lamps are fitted in order to maintain sterility.

  12. Quarantine area: • After filling, sealing & sterilization, the parenteral product are held up in quarantine area. • Randomly samples were kept for evaluation. • The batch or product pass the evaluation tests are transfer in to finishing or packaging area. • Finishing & packaging area: • Parenteral products are properly labelled and packed. • Properly packing is essential to provide protection against physical damage. • The labelled container should be packed in cardboard or plastic container. • Ampoules should be packed in partitioned boxes

  13. EVALUATION OF PARENTERAL PREPARATIONS • The finished parenteral products are subjected to the following tests, in order to maintain quality control: • A) Sterility test • B)Clarity test • C)Leakage test • D)Pyrogen test • 1) rabbit method • 2)LAL test (Limulus amebocyte lysate) • E)Assay

  14. Thank YOU

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