The presentation contains the advancements in the technologies developed in the formulation of sterile liquids as well as modern devices to administer the formulation.

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9. INTRODUCTION:
 BLOW-FILL-SEAL TECHNOLOGY IS A MANUFACTURING TECHNIQUE USED TO PRODUCE SMALL,
(0.1ML-99ML) AND LARGE VOLUME, (100ML AND ABOVE) LIQUID FILLED CONTAINERS.
 BLOW-FILL-SEAL IS A SPECIALISED PACKAGING TECHNOLOGY USING IN-LINE FORMING AND
SEALING A POLYMERIC MATERIAL TO A CONTAINER OF CHOICE.

10. CONCEPT AND WORKING:
 THE BASIC CONCEPT IS FORMATION, FILLING AND SEALING OF PLASTIC CONTAINER IN ASEPTIC
ENVIRONMENT.
 THE BFS CYCLE CAN BE DIVIDED INTO FOLLOWING MAIN STEPS:-
STEP 1: PARISON EXTRUSION
STEP 2: CONTAINER MOULDING
STEP 3: CONTAINER FILLING
STEP 4: CONTAINER SEALING

11. Step 1:
Parison Extrusion
Firstly, pharmaceutical plastic resin is
vertically heat extruded through a
circular throat and forms a tube called
Parison.

12. STEP 2:
CONTAINER MOULDING
• THE EXTRUDED TUBE IS THEN ENCLOSED
WITHIN A TWO PART MOULD AND THEN THE
TUBE IS CUT ABOVE THE MOULD.

13. STEP 3:
CONTAINER FILLING
• THE MOULD IS TRANSFERRED TO STERILE
FILLING ZONE WHERE FILLING NEEDLES CALLED
MANDRELS ARE LOWERED AND USED TO
INFLATE THE FLAT TO FORM CONTAINER
WITHIN THE MOLD.

14. STEP 4:
CONTAINER SEALING
• THE MANDREL IS USED TO FILL THE CONTAINER
WITH SOLUTION, FOLLOWING FILLING, MANDRELS
ARE REMOVED AND SECONDARY TOP MOULD
SEALS THE CONTAINER.

15. NEXT STEP: CONTAINER
DISCHARGE
• FILLED AND SEALED CONTAINERS ARE
THEN CONVEYED TO LABELLING AND
PACKING SECTIONS.

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22. • 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.

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36. 1. LIPOSOMES
• PROMISING IN SUSTAINING THE DRUG RESIDENCE TIME WITHIN LUNG, IMPROVING THERAPEUTIC
INDEX, AND DELAYING SYSTEMIC DILUTION AND THEREBY, REDUCING SIDE EFFECTS AND TO
CONTROL THE EXTENT OF RELEASE.
• DELIVERY OF CORTICOSTEROID FOR ASTHMA, RIBONUCLEOTIDES FOR RESPIRATORY INFLUENZA
AMINOGLYCOSIDES (TOBRAMYCIN SULPHATE, AMIKACIN SULPHATE) AND OTHER ANTIBIOTICS
(CIPROFLOXACIN) FOR LOCAL PULMONARY INFECTIONS AND CYSTIC FIBROSIS HAS BEEN
REPORTED USING LIPOSOME TECHNOLOGY.
• IN LIPOSOMAL DPI FORMULATIONS, DRUG ENCAPSULATED LIPOSOMES ARE HOMOGENIZED,
DISPERSED INTO CARRIER AND CONVERTED INTO DPI BY SPRAY AND / OR FREEZE DRYING.
• ON INHALATION, DRUG ENCAPSULATED LIPOSOME’S GET REHYDRATED IN LUNG AND RELEASE
DRUG OVER A PERIOD OF TIME.
• FATTY ACID ESTERS WERE INCORPORATED IN THE LIPID PORTION OF LIPOSOME’S FOR
PROLONGED STEROID RETENTION IN THE RESPIRATORY TRACT.

37. • THE SUCCESS ACHIEVED WITH LIPOSOMES STIMULATED THE SEARCH FOR OTHER VESICLE
FORMING AMPHIPHILES WHICH LED TO THE DEVELOPMENT OF NIOSOMES.
• NON-IONIC SURFACTANTS WERE AMONG THE FIRST ALTERNATIVE MATERIALS STUDIED.
• DRUG TARGETING OF ANTICANCER DRUGS LIKE METHOTREXATE AND DOXORUBICIN HAS BEEN
ACHIEVED BY NIOSOMAL FORMULATIONS.

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44. PYROGEN
TEST
LAL TEST
RABBIT TEST
(IP,BP, USP,
EP)

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49. • DUOJET PREFILLABLE SYRINGE SYSTEMS
AND LYOPHILIZED DRUG RECONSTITUTION
DEVICES: ITS WORK ON THE
ADVANCEMENT OF PARENTERAL
TECHNOLOGY, DEVELOPING MEDICAL
DEVICES FOR PHARMACEUTICAL CLIENTS
WHICH MEET PATIENT NEEDS FOR SAFETY,
PRECISION AND SIMPLE EASE OF USE IN
DRUG RECONSTITUTION AND DELIVERY
• VARI-VIAL™ PREFILLABLE SYRINGE: VARI-VIAL
™ - A PRE-FILLABLE SYRINGE AND
NOVEL BOTTOMLESS VIAL CAPABLE OF
BEING PROCESSED ON STANDARD 'IN-HOUSE
OR OUTSOURCED' VIAL
PRODUCTION MACHINERY.

50. • INSULIN PENS: INSULIN PEN IS THE
COMBINATION OF THE SYRINGE AND
INSULIN CARTRIDGE INTO ONE.
• IT HAS MADE MULTIPLE INSULIN
INJECTIONS MORE CONVENIENT,
PORTABLE AND ACCEPTABLE.
• DISPOSABLE AND SEMI-DISPOSABLE
INJECTION PENS: PATENTED DISPOSABLE
'DOSE MEMORY' PENS AND 'CLICK-ON'
PEN NEEDLES MAKE GIVING INJECTIONS
MORE CONVENIENT

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54. • INSULIN PUMPS: THE INSULIN PUMP IS A SMALL PORTABLE DEVICE (ABOUT THE SIZE AND
WEIGHT OF A PAGER) THAT DELIVERS INSULIN CONTINUOUSLY THROUGH A FINE PLASTIC
TUBE INTO A SITE UNDER THE SKIN. USERS WILL NEED TO GO THROUGH A COMPREHENSIVE
TRAINING.
• THE INSULIN PUMP GENERALLY GIVES YOU BETTER CONTROL AND MORE MEAL FLEXIBILITY
BUT IS COSTLY AND STILL REQUIRES FREQUENT BLOOD SUGAR MONITORING.
• THE CATHETER AT THE END OF THE INSULIN PUMP IS INSERTED THROUGH A NEEDLE INTO THE
ABDOMINAL FAT OF A PERSON WITH DIABETES.
• DOSAGE INSTRUCTIONS ARE ENTERED INTO THE PUMP'S SMALL COMPUTER AND THE
APPROPRIATE AMOUNT OF INSULIN IS THEN INJECTED INTO THE BODY IN A CALCULATED,
CONTROLLED MANNER.

55. • INFUSION PUMPS: COLLEAGUE CX INFUSION PUMP WITH GUARDIAN FEATURE. FROM
SIMPLE INFUSIONS TO MEDICATION THERAPIES REQUIRING COMPLEX DOSE CALCULATIONS.
• GUARDIAN FEATURE TO HELP REDUCE MEDICATION ERRORS BY ALERTING STAFF WHEN
PROGRAMMED DOSES ARE NOT MET WITHIN INSTITUTIONAL LIMITS
• PCA II PUMP INNOVATIVE IN PAIN MANAGEMENT: THE CONVENIENCE OF SAFE AND PRECISE
PATIENT CONTROLLED ANALGESIA IN A FLEXIBLE SYSTEM DESIGNED WITH ADVANCED
TECHNOLOGY. THIS IS PROGRESSIVE, INNOVATIVE, AND EFFECTIVE PAIN MANAGEMENT IN A
SOPHISTICATED, YET SIMPLE-TO-OPERATE, INSTRUMENT.
• FLO-GARD 6201 VOLUMETRIC INFUSION PUMP AND THE FLO-GARD 6301 DUAL-CHANNEL
VOLUMETRIC INFUSION PUMP: FLOW CHECK OCCLUSION ALARM OFFERS AN IN-LINE
RESISTANCE DISPLAY OF INCREMENTAL BACK PRESSURE. FLOW RATE CALCULATION IS
AUTOMATIC AFTER VOLUME AND TIME ARE SELECTED.

57. CONT…
• THE ULTRASAFE® PASSIVE™ DELIVERY SYSTEM OFFERS A COMPLETE
PHARMACEUTICAL DELIVERY SYSTEM AS WELL AS AN EFFECTIVE SOLUTION FOR
PROTECTING WORKERS FROM THE HORROR OF NEEDLESTICKS.
• SPECIFICALLY DESIGNED FOR PRE-FILLED GLASS SYRINGES, THE ULTRASAFE®
PASSIVE™ DELIVERY SYSTEM LEAVES NOTHING TO CHANGE. WITH INNOVATIVE
PASSIVE PROTECTION THAT DELIVERS THE ULTIMATE IN SHARPS INJURY PROTECTION
AND SAFETY, IT PROVIDES A COMPLETE DELIVERY SYSTEM WITH NO CHANGE IN
CURRENT TECHNIQUE.
• ULTRASAFE® NEEDLE GUARDS ARE DESIGNED TO ATTACH EASILY TO MOST PRE-FILLED
GLASS SYRINGES COMMONLY USED WITH VACCINES, LOW MOLECULAR WEIGHT
HEPARINS AND MANY NEW BIOTECHNOLOGY DRUGS.