Hospital Pharmacy Seminar about Medicine manufacturing units in hospitals Clinical Pharmacy Mansoura University

1. Manufacturing
units in hospitals
Hospital Pharmacy Seminar

2. Hospital manufacturing
units

3. Hospital manufacturing units
 The manufacture of medicines is a complex operation
and must conform to GMP requirements of the MCA.
These require a system of QA designed to build quality
into each product at all stages of its manufacture. To
this end, pharmaceutical QA services work closely with
production staff and provide a series of checks, tests
and controls throughout the manufacturing process as
follows:
 Microbiological and chemical testing where appropriate of
ingredients, labels and packaging components, in-process
samples and finished products.
 Checking and approval of all standard operating
procedures and production documents.
 Environmental monitoring in clean and aseptic areas.

4. Hospital manufacturing units
 Validating processes, equipment and procedures.
 Monitoring the performance of sterilizers.
 Pharmaceutical development work, including formulation
development, stability studies and manufacturing and
analytical method development and validation.
 Planned quality auditing at regular intervals.
 Liaison with the MCA.

5. Hospital manufacturing units
 Each manufacturing unit is required to be licensed
under the Medicines Act, holding a manufacturer’s
specials license.
 A requirement of the license is that there must be a
named production manager and named quality
controller for the release for use of all products
manufactured in the unity.
 This is a key role for QA pharmacists and other
appropriately qualified and experienced QA staff.

6. Hospital manufacturing units
 Before releasing each batch for use, the quality
controller has to satisfy him-/herself that GMP, as laid
down in MCA guidance, has been complied with, that all
manufacturing and QC processes have been validated,
that all checks and tests have been carried out and are
satisfactory.
 That all documentation is satisfactory, and that all
other factors which affect the product quality are
satisfactory. This requires highly trained and competent
QC staff who are fully aware of the quality, safety, and
efficacy requirements of pharmaceutical products.

7. Pharmacy manufacturing
units
Total Parenteral Nutrition (TPN), Chemotherapy and
Extemporaneous Preparations

8. Pharmacy manufacturing
units
 The Pharmacy manufacturing units are involved in the
preparation of medicines that are not available
commercially in a ready-to-use format.
 The majority of this work is concerned with aseptic
preparation.
 This is the preparation and supply of products that must
be completely sterile before administration to the
patient.

9. Pharmacy manufacturing
units
 In order for this to be achieved they are made within
special isolators which are supplied with filtered air.
 The majority of aseptically prepared items are either
Total Parenteral Nutrition (TPN) or chemotherapy.

10. Total Parenteral Nutrition
(TPN)
 These contain all the essential
nutrients to sustain a patient if
they are unable to eat food in
the normal way.
 TPN bags containing
carbohydrates, fats and salts in a
1.5 litre formulation are
purchased.
 These standard bags then have
vitamins, trace elements and
extra minerals added as
necessary.

11. Chemotherapy

12. Chemotherapy
 Cytotoxic drugs are used in the treatment of cancer.
 They are supplied in a ready-to-use form to the ward
which means that staff are not exposed to the toxic
nature of the medicine.
 By working within the controlled environment of the
aseptic suite the pharmacy operators are also protected
whilst preparing the medication.
 A variety of devices are made (5-Fu Walkmeds /
Accufusors) which means patients are able to complete
chemotherapy at home, without a stay in hospital.

13. Extemporaneous
Preparations

14. Extemporaneous Preparations
 Whilst most medicines are commercially available, some
dosage forms cannot be purchased from large
companies.
 Extemporaneous preparation describes the work
involved in supplying a medicine in a form or dose that
is not otherwise available.

15. Extemporaneous Preparations
 The technical services departments across both sites are
involved in the manufacture of:
1. Liquid formulations
2. Eye drops
3. Creams
4. Ointments
5. Quality Control

16. Extemporaneous Preparations
 Deals with all aspects of quality control within the
pharmacy manufacturing and purchasing sections.
 Advice is given on COSHH (control of substances
hazardous to health), medical gases and complaints
regarding faulty drug products and sundries.

17. Dialysis solutions

18. Dialysis solutions
 1. Peritoneal dialysis solutions:
 These are sterile solutions
injected into the abdominal
cavity, left for 30-90 min. to
allow exchange between the
solution and the viscera
through the visceral wall
which acts as a semipermeable
membrane and then they are
withdrawn.

19. Dialysis solutions
 1. Peritoneal dialysis solutions:
 These are used to remove toxins from the body or to
accelerate the excretory function of the kidney in cases of
acute renal insufficiency.
 These solutions contain glucose and electrolytes.

20. Dialysis solutions
 2. Hemodialysis solutions:
 Used in severe cases of renal failure.
 Here, the blood leaves the body from an artery through a
polyethylene catheter into a dialyzing cell in which
exchange occurs between the blood and the dialysis
solution through a semi-permeable membrane to clean the
blood from wastes, then the blood enters the body
through a vein.
 Time of passage should not exceed the clotting time [4-6
hours]
 Hemodialysis solutions contain: electrolytes,
preservatives, accelerators and glucose (to act as a
pumping system by rendering the solution hyperosmotic)

21. Dialysis solutions
Diagram of Hemodialysis set

22. Sterilization

23. Sterilization
 Sterilization (or sterilisation) is a term referring to any
process that eliminates (removes) or kills (deactivates)
all forms of life and other biological agents, including
transmissible agents (such as fungi, bacteria, viruses,
prions, spore forms, etc.) present in a specified region,
such as a surface, a volume of fluid, medication, or in a
compound such as biological culture media.
 Sterilization can be achieved with one or more of the
following: heat, chemicals, irradiation, high pressure,
and filtration.

24. Sterilization
 Sterilization is distinct from disinfection, sanitization,
and pasteurization in that sterilization kills,
deactivates, or eliminates all forms of life and other
biological agents
 In general, surgical instruments and medications that
enter an already aseptic part of the body (such as the
bloodstream, or penetrating the skin) must be sterile.
 Examples of such instruments include scalpels,
hypodermic needles and artificial pacemakers.

25. Sterilization
 This is also essential in the manufacture of parenteral
pharmaceuticals.
 Preparation of injectable medications and intravenous
solutions for fluid replacement therapy requires not
only sterility but also well-designed containers to
prevent entry of adventitious agents after initial
product sterilization.

26. Blood Banks

27. Blood Banks
 A blood bank is a cache or bank of blood or blood
components, gathered as a result of blood donation or
collection, stored and preserved for later use in blood
transfusion.
 The term "blood bank" typically refers to a division of a
hospital where the storage of blood product occurs and
where proper testing is performed (to reduce the risk of
transfusion related adverse events).
 However, it sometimes refers to a collection center, and
indeed some hospitals also perform collection.

28. Blood products

29. A. Concentrates of platelets
and white blood corpuscles
Method of preparation:
 Blood (fresh)  low speed centrifugation  RBCS
sediments + White blood corpuscles platelets in plasma.
 Plasma (WBC. and platelets)  High speed centrifugation
 Concentrated platelets in plasma.
Uses:
 Treatment of patients with leukemia
Storage:
 This packed in disposable plastic blood bags or suitable glass
bottles

30. B. Concentrated human red
blood corpuscles
Method of preparation:
 Blood (fresh)  centrifugation  40% of fluid of total
volume is removed from the supernatant
 It must be of suitable viscosity for administration [If with
high viscosity use BSWFI (Bacteriostatic sterile water for
injection)]
Storage:
 Preparation should be packed in glass bottles and used
within 12 hr of preparation to avoid the risk of bacterial
contamination

31. C. Fresh frozen plasma
Method of preparation:
 Blood (fresh)  After few hrs. of collection make high
speed centrifugation  plasma  Stored in frozen state
below -30°C. Before used it must be immersed in water
bath at 37°C for about 45 min.
 Here not sterilized as taken from sterile blood & prepared
under aseptic conditions
Uses:
 Treatment of minor hemorrhage

32. D. Dried human plasma
Method of preparation:
 Plasma is difficult to filter and It is not practicable to sterilize
it by filtration but Freeze - drying [Lyophlization] is a suitable
method.
 State: The dried plasma is a light to deep, cream - colored
powder.
 It is reconstituted to the original volume with sterile water for
injection at room temperature in about 10 min.
Uses:
 Treatment of patients suffering from burns, scales, crash
injuries.
Storage:
 Below 50°C protected from light.

33. E. Dried human fibrinogen
Method of preparation:
 Plasma  Ethanol at 0°C & PH 7  Fibrinogen ppt. [as
least soluble]  It is the least soluble one of plasma
proteins.
 Further purification by centrifugation.
 Deposit is dissolved in citrate saline solution, As citrate
bind Ca2- ions and prevent spontaneous clotting of the
product.
 The solution is frozen and dried  White powder.
 It is reconstituted using sterile water for injection before
use.

34. E. Dried human fibrinogen
Uses:
 For treatment of fibrinogen deficiency, associated with
pregnancy.
 Repair severed nerves (plastic surgery)
 Aid in adhesion of grafts (skin graft)
Storage:
 Below 25°C protected from light.

35. Administration Methods

36. A. Gravity Flow
 The majority of
infusion are
administrated by the
gravity method.
 In this method the
container must be
supported above the
patient in order for the
solution to flow

37. A. Gravity Flow
 Flow will not begin until the pinch clamp is opened and
air is allowed to enter the container (For a plastic
infusion container, however, air is not required in order
for the solution to flow)
 The rate can be adjusted by counting the drops that
enter the drip chamber & The clamp on the tubing is
then adjusted to regulate flow.
 However, Crass and Vane: reported that intravenous
fluid delivery via gravity-flow I.V. infusion system is
highly inaccurate so to ensure appropriate fluid
delivery, better monitoring or improvement of I.V. fluid
administration systems or the use of electronic infusion
control devices is recommended.

38. B. Piggyback Administration
 Piggyback administration is a
method of I.V. administration by
which solution from two
containers flow into the patient's
vein through common tubing and
a common injection silence (vein-
puncture )
 One solution generally is a large-
volume parenteral for continuous
infusion and is sometimes
designated as the primary
solution.

39. B. Piggyback Administration
 The other solution Is usually an Intermittent, Infusion
such as an antibiotic, that may be referred to as the
secondary, or piggyback, solution.
 The piggyback solution is most frequently 50 or 100 ml
of 5% dextrose injection or 0.9% sodium chloride
injection (act as vehicle for the 2nd drug)
 The piggyback container may be a glass bottle or a
plastic container referred to as a mini bottle Mini-Bag
container

40. B. Piggyback Administration
 The primary solution container and the piggyback
solution container are connected in a "Y" type tube
 A continuous, straight administration set connects the
primary solution container to the patient
 This set has a "Y" injection site for the attachment of a
second administration set, which connects to the
piggyback solution container.

41. B. Piggyback Administration
 The use of these two sets together allows for the
efficient, safe administration of piggyback solutions.
First, the primary solution drip rail is established
 At the appropriate time, the clamp to the piggyback set
can be opened to allow the piggyback solution to flow
through the tubing.
 Because the piggyback solution is hanging higher the
primary solution, the greater pressure allows it to flow
in preference to the primary solution

42. B. Piggyback Administration
 The piggyback solution is prevented from (lowing up and
into the primary solution container by a one-way check
valve on the primary set  This check valve allows the
solution to flow from the primary bottle the patient,
but not the opposite way.
 Used for administration of some drugs that can't be
admixtured due to delayed type incompatibilities
 Alternative system  In some types we can discard the
use of mini piggy bags by injection of the 2nd drug
[intermittent] in the dripping chamber at certain
predetermined times.

43. C. Pumps and controllers
There are different types of pumps such as:
 Syringe pumps
 Peristaltic pumps
 Volumetric pumps
Volumetric pumps will be used as an aid for the infusion of
the following types of solutions:
 Parenteral nutrient (hyper-alimentation liquids or TPN)
 Low-dose insulin infusion
 Lidocaine drips
 Dopamine
 Heparin infusion

44. C. Pumps and controllers
(cont.) Volumetric pumps will be used as an aid for the
infusion of the following types of solutions:
 Intravenous fats
Small volume administration
 Nitroprusside
 Magnesium infusion
 Blood (emergency only)
 Elemental diets [so used for certain drugs]
 Syringe-pump infusion & Peristaltic pumps are of limited
use

45. Thank you!
For your time.