Sterile Products

Sterile products Sterility: The Absence of living organism Aseptic Technique: Procedure that maintains sterility. Pyrogen: (Fever producing): metabolic By-products of live or dead Organisms Tonicity (Osmotic Pressure) 1. Hypotonic Solutions : lower osmotic pressure than blood or 0.9% NaCl (leads to Cell Expansion ,Pain , Hemolysis ) 2. Isotonic Solutions :same as Blood 3. Hypertonic Solutions: Administered through a Large vein (Subclavian or Internal Jugular) to Avoid Phlebitis and to achieve Dilution Cleans Rooms: Areas that are constructed to minimize the contamination of sterile products using: 1. Hepa Filters (high Efficiency Particulate Air) Classified as 10,000 = no more than 10,000 particles of 0.5 mm or larger per Cubic foot of air. 2. Positive-Pressure Airflow :pressure inside room 3. Stainless Steel Counters :bigger than outside 4. Uniform Air Flow: A. Horizontal laminar: use higher efficiency Hepa (Class 100) B. Vertical laminar: the same Inspected using Dicotyl Phthalate (Particle size = 0.3 mm that should pass the Hepa Filters)

Sterilization Methods A.Thermal 1. Moist heat (Autoclave): Saturated Steam under pressure at 121 c for 15 minutes. 2. Dry heat : 160 c for 120 minutes B-Chemical Gas (Ethylene Oxide ): surfaces and porous materials ,surgical Dressings. C-Radioactive Sterilization: Pre-packages that cannot be exposed, Surgicals, Ophthalmic Ointments. D-Mechanical Sterilization (filtration): Removes but doesn’t destroy microorganisms (for Thermolabiles) 1. Depth Filters (Glass or Porcelain ) 2. Screen Membrane (Cellulose Esters , Synthetic Polymers ) A. Particulate Filter: Removes particles of Glass, Plastic, Rubber from emulsions, Dispersions, Parentrals B. Microbial Filters (Cold Sterilization ) C. Final Filters (Particulate or Microbial ) remove particles and Micro Organism from IV infusion Packaging of Parentral Products: A-Container Types : 1. Ampoules: From glass, single use, break at score line. Disadvantage: Need to be filterd as glass particles fall in. 2. Vials : Glass or plastic closed with a Rubber stopper and sealed with an Aluminum crimp

Advantage: 1. Can hold multiple doses (Bacteriostatic added) 2. Dg is easier to remove than ampoule 3. No risk of glass particles contamination Disadvantage: 1. Rubber can enter the solution 2. Multiple withdrawals can lead to microbial contamination N.B. Unstable Solutions are packaged as powder that is reconstituted using Sterile water or Sterile NaCl for inj. Lyophilized (freeze dried) powder increase Dissolution N.B.2 Double Chamber Vials: The Upper part contains (Water) and the lower (Powder) and between them a Rubber Closure (press the upper part so that Closure falls and the two parts mix) Advantage: No need of Twice Penetration increasing Microbial Contamination

3. Add-Vantage: Vial is attached to the top of an IV minibag of diluent and when the Rubber Diaphragm is Dislodged from the vial the IV solution dissolves the drug 4. Prefilled Syringes In emergency ex. Atropine, Epinephrine 4.5 IVAC’S controlled-release infusion system (CRIS): Plastic disposable adaptor which allows the quick transfer of a drug solution into an infusion container,a vial is hooked to the adaptor ,the value device is turned ,and the vial contents will enter the infusion line mixing with infusion mixing with the

infusion solution flowing into the patient ,the unit avoids the need to initially mix the additive with the primary infusion solution 5. Prefilled Cartridges (parental Packages) Consists of a Plastic Cartridge Holder and a Drug Solution cartridge with a needle attached ex. (Morphine, Meperidine) 6. Infusion Solution: A. Small Volume Parentrals: less than 100 ml B. Large volume Parentrals: Greater than 100 ml 7. Package material A. Glass: easy inspection ,less interaction with drug B. PVC Polymer and Poly-Olefin polymer : Durable , Safe Parentral Administration Routes: A. subcutaneous : (Abdomen ,Arm , Thigh ) ex. Insulin B. Intramuscular : not more than 5 ml , prolonged action ex. Prednisolone C. IV : problematic overdose , antibiotics, Cardiac drugs D. Intra-Dermal (superficial skin layer ): limited volume ,skin tests ,vaccines E. Intra-arterial : high drug concentration with liitle dilution ,radio-opaque materials ,thrombolytic drugs , antineoplastic F. Intracardiac G. Hypo-Dermoclysis :large vol. of solution into subcutaneous tissues to provide a continuous Abundant drug supply Ex. Antibiotics for children H. Intraspinal: into spinal column, Lidocaine in surgery I. Intraarticular: in joint space, Corticosteroids for Arthritis

J. Intrasynovial: into joint fluid K. Intrathecal: spinal fluid, Antibiotics, Cancer chemotherapy

Parentral Preparations A. IV Admixtures : (for Continuous Infusion ) One or more sterile drug added to IV fluid (Dextrose or NaCl) B. IV fluids and Electrolytes 1-Fluids Ex. Sterile water, sodium chloride, dextrose, ringer solution Usage: Vehicle, Correct body fluid and electrolyte disturbance, Caloric source of nutrition A-Dextrose (D-glucose) solution 5 % Can be used as hydrating, 10 % = carbohydrate source Disadvantage: 1. Ph 3.5-6.5 affecting Acid sensitive drugs 2. 15% con. Has to be administered in a Central vein 3. Caution with Diabetic mellitus patients B-Sodium Chloride: 0.9 %( Saline) 0.45% half-normal saline, 0.225% % quarter normal saline Usage: 1. NaCl for injection : Fluid and Electrolyte replacement

2. Bacteriostatic NaCl : For multiple reconstitution ,contains (Benzoyl Alcohol , Propyl Paraben ) C-Waters (Sterile water for injection, Bacteriostatic water for injection) Usage: Dilution of Dextrose or Sodium chloride D-Ringer’s solution Usage: After Surgery for fluid and Electrolyte replacement 1-Hartman’s Lactated Ringer solution: (Na lactate, Na chloride, potassium chloride, Ca chloride) with Dextrose 5% 2-Ringer’s solution same without Na lactate Electrolyte preparations: a. Cations (Na,k,Ca,Mg) 1-Sodium chief Extracellular cation: (NaCl, Na acetate, Na2Po4) Importance: A. B. C. D. E.

Osmotic pressure Tissue hydration Acid-base balance Nerve –impulse transmission Contractility

2-Potassium: (kcl , k acetate ,k2 po4) , Chief intracellular Cation Importance: A. B. C. D.

Cardiac muscle contraction Neuromuscular excitability Carbohydrate metabolism Protein synthesis

3-Calcium (Cacl2, Ca Gluconate )

Importance: A. B. C. D. E.

Cardiac function Nerve impulse transmission Muscle contraction Bone formation Capillary and cell permeability

4- Magnesium (mg2so4) Importance: A. Neuromuscular transmission B. Muscle excitability C. Plays a vital part in enzyme activities B-Anions 1-Chloride: major Extracellulatr anion (Nacl , Kcl , Cacl2) Importance: A. Osmotic pressure B. controls ph 2-Phosphate: major intracellular anion (K2po4 ,Na2po4) Importance: Enzyme activities, affects ca +2 levels, affects acid-base balance 3-Acetate (K acetate , Na acetate ) Importance: A. Bicarbonate precursor which provides alkali B. Affects acid-base ph C.Parentral Antibiotic preparations (powders) Usage: Serious infection Git is contraindicated ex. Ileus

Methods: direct IV, short term infusion, IM, Intrathecal D.Parentral Antineoplastic: Ignored as think is not important E.parentral biotechnology: same

Irrigating Solutions :( not for iv infusions ) A. Topical : wounds ,dressings , surgical instruments B. Infusion of irrigating solutions : 1. 2. 3. 4.

In surgery to maintain integrity of the surgical field Remove blood clear field of view Neosporin antibiotic is added to avoid contamination

C.Dialysis (Dilaystaes) Peritoneal: 1. Hypertonic solution in the peritoneal cavity through catheter 2. solution contains dextrose + electrolyte it removes harmful substances by osmosis then drained 3. Antibiotics or heparin can be added Haemodialysis: Blood passes through a Dialyzing membrane that removes harmful substances then blood re-enters through the vein Needles and Syringes: A. Hypodermic needle (stainless steel or aluminum) 1. Needle gauge (outside diameter of the needle shaft ) : The larger the number the smaller the diameter (27-13) A. Subcutaneous: 24-25 g

B. Intramuscular: 19-22 g C. Parentral compounding: 18-20 g

2. Bevels: Edges cut into needle tips to facilitate penetration A. Regular: most common, subcutaneous ,IM, Hypodermoclysis B. Short: when shallow penetration, IV C. Intradermal: most beveled edges 3-Needle Lengths (0.25 inch -6 inches) A. parentral compounding: 1.5 inch B. intradermal and subcutaneous : 0.25-5/8 inch C. IV infusion: 1.25-2.5 inch D. Intracranial: 3.5 inch B-Syringes Consists of a glass or plastic barrel with plunger at one end and at the other a small opening that carries the head of the needle 1-Leur Syringe: First made, universal needle attachment Volume: 0.3-60 ml N.B. Insulin syringes: 100 units /ml instead of volume 3-Calibrations: metric or English

4-Syringes Tips: A. Leur lok : threaded so that the needle fits tightly for antineoplastics B. Leur-slip : unthreaded therefore it can fall C. Eccentric :off center , allows the needle to remain parallel to the injection site and minimize various irritations D. Catheter : for wound irrigation and enteral feedings Intravenous Drug Delivery A. injection sites 1. Peripheral vein: A. B. C. D.

Non irritating drugs Isotonic solutions Short term IV Dorsal forearm for the venipuncture

2. Central vein: A. B. C. D.

Irritating drugs Hypertonic solutions Long term IV Large veins in the thoracic activity

Ex.subclavian B-infusion methods: 1-continous-drip infusion: Slow infusions of an iv preparation to maintain a therapeutic drug level, Electrolyte replacement A-Flow rate: ml/hr, dps/min, mg/min B-Administration Narrow therapeutic index drugs (Aminophylline, heparin, epinephrine, norepinephrine, phenylephrine) 2-Intermittent infusion (mostly Antibiotics)

A-Direct (bolus): Rapid small volume of undiluted drug Used to 1. Emergency for immediate effect 2. Drugs that cannot be diluted 3. Achieve therapeutic serum drug quickly B-Additive Set infusion: 1. Small amounts, Diluted drug 2. Using a volume control device 3. The fluid chamber is attached to an independent fluid supply or under the primary IV line C-Piggy back method Usage: When the drug cannot be mixed with the primary solution therefore a special coupling for the primary IV tubing allows infusion of a secondary solution through the primary system Advantage: 1-no need for a second venipuncture or dilution of the supplementary preparation D.Devices for Intermittent Infusion (Scalpvein, Heparin-lock, butterfly Set) Allows intermittent delivery without the need for multiple Venipuncture or prolonged venous access with continuous infusion N.B. To prevent clotting in the Cannula a dilute heparin or Nss solution added Advantages of intermittent infusion:

1. For those who don’t need or are affected by large volumes ex. Congestive Heart. 2. No need for a bottle attachment so more freedom

Pumps and Controllers: Used when the Gravity lead to inaccurate dosing or risk 1-Pumps: A-Mechanisms: 1. Piston cylinder 2. Linear peristaltic B-Types: A-Volumtric pumps: Intermittent infusion Ex. Antibiotics Continuous infusion Ex. Parentral nutrition, anticoagulants,antiasthmatics. B-syringe pump: Intermittent or continuous (Antibiotics, opiates) in conc. Form C-Mobile Infusion: For Ambulatory and Home patient (Chemotherapy, Opiates) D-Impantable Pump:

Under the skin providing a continuous release the reservoir in the pump is refilled by injection through a latex diaphragm Ex. Opiates

E-Patient Controlled Analgesics Pump: Administer narcotics on demand Pump advantages: A. Constant, Accurate flow rate B. Detect infiltrations, occlusions, air 2-Controllers (no pumping pressure) Control the infusion by counting drops electronically (volumetric control) Advantage: 1. Less complex and expensive 2. Accurate Disadvantage: Not for Arterial infusion or small vein infusion IV Compatibilities: Types: 1-Physcial: Visible change in the solution appearance A. ex. Nahco3 +hcl = co2 evolution B. color changing or darkening , precipitation

2-Chemical: degradation of one or more admixed drugs A- complexation: reduction leading to inactivation Ex. Ca+ Tetracycline

B-Oxidation: drug looses protons to the other leading to colour change and therapeutic inactivity C-Reduction: Drug gains electrons D-photolysis (chemical decomposition): Can lead to Hydrolysis or oxidation leading to discoloration 3-Therapeutic: response other than what was expected Ex. when giving penicillin G after Tetracycline its Bactericidal effect decrease because tetracycline is bacteriostatic while Pen. G is active against proliferating bacteria Factors affecting IV compatibility: A. Ph = risk increase when ph of components differ significantly because Acid + Base = water + salt = may be insoluble B. Temperature :temp speeds up degradation so put in a refrigerator or freeze C. Degree of Dilution: the more diluted the less interaction D. Length of time in solution : the longer the contact time the more interaction E. Order of mixing :incompatible drugs should be not be mixed together at the same time ex. Ca and po4 E.Hazards of Parentral Drug therapy: A-Physical:

1-Phlebitis: Minor complication, results from vein injury or irritation Treatment: Proper IV insertion, irritating drugs dilution, decreasing infusion rate 2-Extravastations: When Dugs have vesicant properties (Drug escaping into subcutaneous tissues surrounding the vein) Ex. Antineoplastics Treatment: A. B. C. D.

Injecting hydrocortisone or another Antinflammatory into the area Antidote injection Cold compress Facilitate drug-antidote interaction

3-Irritaion: another site of injection, moisturizing lotion 4-pain: in peripheral concentrated drugs therefore change to central or dilute 5-Air embolism: fatal 6-infection: Usually in central IV lines during insertion or tubing changes (local or generalized septicemia) Treatment: follow central line care protocol 7-Allergic Reactions: Hypersensitivity to IV solutions 8-Central Catheter misplacement: Can lead to air embolism or pneumothorax Treatment:

Radiology is done to be sure that catheter has passed into the subclavian vein and reduced to the level of vena cava 9-Hypothermia: A. Lead to shock and cardiac arrest B. allow to reach the room temperature 10-Neurotoxicity: due to preservatives in Intrasecal or Intraspinal Use preservative free Mechanical Hazards: A-Infusion Pumps or Controller Failure: 1. Runaway infusion 2. Fluid overload 3. Incorrect dosage B-iv tubing: Can become Split, Cracked, Produce Particles, Contamination C-Particulate matter: cause Embolism D-Glass containers: Injury E-Rubber Vial Closure: interaction Therapeutic Hazards: 1. Drug instability : Therapeutic ineffectiveness 2. Incompatibility : toxicity or reduced their effectiveness 3. Labeling Errors: administering wrong drug or dose 4. Drug Overdose: due to runaway infusion , controller or pump failure 5. Preservative toxicity :serious 6. Premature Children receiving Benzyl Alcohol develop a fatal Acidotic Toxic Syndrome (gasping syndrome)