Pilot plant scale-up is a branch of the pharma companies in which a lab-scale formula is converted into a commercially viable product by creating a reliable manufacturing technique. The same techniques employed in dosage form Research and Development are adapted to multiple output volumes, frequently larger than those obtained during Research and Development. There is always a requirement for an intermediate batch scale describing techniques and imitating those in commercial manufacturing in any new or established pharmaceutical sector. This is accomplished by testing the formula’s ability to survive batch-scale and process changes.
Pilot plant scale-up is a branch of the pharma companies in which a lab-scale formula is converted into a commercially viable product by creating a reliable manufacturing technique. The same techniques employed in dosage form Research and Development are adapted to multiple output volumes, frequently larger than those obtained during Research and Development. There is always a requirement for an intermediate batch scale describing techniques and imitating those in commercial manufacturing in any new or established pharmaceutical sector. This is accomplished by testing the formula’s ability to survive batch-scale and process changes.
Rxcare online pharmacy store in USA. Rxcare pharmacy Provide compounding-only pharmacy long trusted to provide the highest quality compounded medications.
Premium pharmacy drawer systems, maximum storage space within a small footprint, metal product, long lasting and slick to use. Variety of sizes available. Store all sorts of medical devices, locking option available.
The X series combines a range of highly popular pharmacy drawer systems that are used through-out Europe. Designed specically for the storage of medicines within pharmacies and healthcare facilities the robost structure efficiently provides high density medicine storage with a minimal use of floor space.
•High quality design and materials used, the robost design significantly increases the lifetime of the drawers far exceeding the lifetime of timber drawer systems and inferior products.
•Angled drawers enable FIFO prinicple of drug storage
•Mesh drawer bottoms prevent collection of dust and increase visiblity of medicine packs from below
•Clear Labelling
•Drawers fully extended increasing storage capacity
•Cladding packs available in a wide range of finishes
ProductsHX Pharmacy Drawer System
Full height high density medicine storage drawers.LX Pharmacy Drawer System
Angle drawers to increase visibility of medicines and enable FIFO principle.VX Pharmacy Drawer System
'V' shaped drawers increasing medicine visibility and enable FIFO principleBX Pharmacy Bench Drawer System
Flexible bench drawer units with wide choice of sizes and accessories.
Pharmacy Storage & Pharmacy ShelvingY Series Pharmacy Drawer & Shelving UnitsA range of pharmacy storage and pharmacy shelving equipment designed specifically for dispensaries within pharmacies, hospitals and healthcare facilities.
All parts, including worksurfaces, are interchangeable so layouts can be amended at any time in the future to suit any changes in work flow or best practise.
Maximises stock density holding between three and four times the amount of stock held on traditional shelves.
•Increase dispensing efficiency
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Five Pharmacy Rules Hospitals Can't Afford To Ignore In 2016CompleteRx
With each new year comes increased regulations that affect the hospital ecosystem. This webinar will take a look at the approved and proposed regulatory requirements for hospital pharmacies that have been published to be proactive and ensure compliance.
Basic principles of compounding and dispensing (Prescription) MANIKImran Nur Manik
Weight, measure and units calculation for compounding and dispensing. Fundamental operation in compounding. Good pharmaceutical practices in compounding and dispensing. Containers and closures for dispensed products. Responding to prescription, labeling of dispensed medications.
USP <800> aims to improve the health and safety of healthcare workers in hospitals, compounding pharmacies, and other areas where hazardous drugs are handled. This presentation overviews the history of healthcare worker protection against hazardous drugs such as chemotherapy and other antineoplastic compounds.
This set of slides highlights changes that the December 2014 USP <800> introduced to the USP <797>. This information offers insights into key compliance measures that prevent contamination of the work environment and thus protect the workers who handle the NIOSH-listed drugs than can cause health problems for laboratory and pharamacy workers.
One key to compliance is the right personal protection equipment (PPE). This slide presentation points to sources for additional information on specific products that satisfy USP <800> protocols.
Aseptic Area and Microbial Control. - Pharmaceutical Microbiology (SYBpharm) ...Kiran Shinde
Prof.Mr.Kiran K. Shinde (M.Pharm), Assistant professor (VNIPRC)
Pharmaceutical microbiology (Second year b.pharm) (3rd semester)
Introduction to Aseptic area & room
Designing of Aseptic Room
Laminar Airflow Equipment
Sources of Contamination & Method of Prevention
Classification of Aseptic Area-Room
Testing of Clean Aseptic Room
Aseptic techniques are employed to provide protection to ophthalmic and parenteral products by preventing the entry of microbial and particulate contamination.
Prevention of microbial contamination is also required to remove pyrogens and toxic bacterial products.
Sample of a Standard Operating Procedure (SOP) for Cleaning and Sanitizing Ca...NACPT Pharma College
To clean and sanitize the Closed Loop Extraction System in preparation for future runs. This will prevent contamination of future batches and keep gaskets fresh. Cleaning and sanitizing the system will also maintain the equipment, reduce corrosion and degradation of components within the system and protect the longevity of the system for use.
This presentation contains general guidelines and basic requirements of manufacturing of sterile medicinal products. This presentation is useful for training to the people involved in manufacturing of sterile pharmaceuticals or medicines.
Cleaning and Disinfecting iv Hoods and RoomsJerry Fahrni
There are plenty of rules regarding when and how pharmacy iv rooms should be cleaned and disinfected. This presentation gives a basic overview of those rules as found in USP Chapter <797>
Infection Control Guidelines for Pharmacy [compatibility mode]drnahla
Infection Control Guidelines for Pharmacy
Infection Prevention in Pharmacy
Dr. NAHLA ABDEL KADERوMD, PhD.
INFECTION CONTROL CONSULTANT, MOH
INFECTION CONTROL CBAHI SURVEYOR
Infection Control Director, KKH.
2. PRIMARY ENGINEERING CONTROLS (PECS)
PEC is a device or a room that provides an ISO class 5 environment for
compounding CSPs (compounded sterile preparations).
PEC relies on high-efficiency particle air (HEPA) filter (which is ≥ 99.99%
efficient in removing particles as small as 0.3 microns in size).
Types NESH
1. Laminar Airflow Workbench
2. Biological Safety Cabinets
3. Compounding Aseptic
Isolators
4. Compounding Aseptic
Containment Isolators
1. Compounding Aseptic
Isolators
- Microsphere IsoTech (vertical
airflow)
3. THE ARCHITECTURE
USP <797> NESH
1. Buffer area (“cleanroom”) – area
where a PEC is located and
where activities such as
preparation, compounding, and
staging CSPs occur (must meet
or exceed ISO 7).
2. Ante area – space for
handwashing, garbing and
product decontamination (must
meet or exceed ISO 8).
The installation of Microsphere
creates a special compounding
environment.
Our IV room is a combination of
buffer area and ante area (not
separation of 2 areas into 2 different
rooms).
It is not recommended but is
acceptable in accordance with USP
<797> , yet still might not be in
compliance with the upcoming
<800>.
4. IV ROOM DEVICES
Types NESH
1. Pharmacy Compounding
Devices
2. Automated Compounding
Devices
3. Repeater Pump
4. Robotic Systems
Pharmacy Compounding
Device – Microsphere
ISO 5.
5. CLEANING AND DISINFECTING - FREQUENCY
USP <797> (minimum
frequency)
NESH
1. ISO 5 PEC
• beginning of each shift
• before each batch
• every 30 minutes when
compounding
• after spills
• when surface contamination is
known or suspended
2. Counters and easily cleanable
work surface – DAILY
3. Floors – DAILY
4. Walls – MONTHLY
5. Ceilings – MONTHLY
6. Storage shelving - MONTHLY
1. ISO 5 PEC (Microsphere) – in
compliance.
2. Counters and easily cleanable
work surface – in compliance.
3. Floors – in compliance.
4. Walls – N/A
5. Ceilings – N/A
6. Storage shelving - in
compliance.
6. CLEANING AND DISINFECTING - STEPS
USP <797> NESH
1. Cleaning with a germicidal
detergent and water will
remove visible solids or soiling
before disinfecting.
2. Cleaning with a germicidal
detergent will leave a residue
that need to be removed from
work surfaces by sterile 70%
alcohol.
3. Disinfecting removes microbial
contamination.
4. Cleaning should be done from
the cleanest area to dirtiest
area.
5. Great care must be exercised
to avoid getting the HEPA filters
wet during cleaning.
Follow the steps and compliance.
1. Germicidal = CaviCide and
Sporicide (used alternatively
weekly – by the end of the
week)
2. 70% alcohol (spray and wipes)
– use for daily cleaning.
3. Cleaning of Microsphere ISO 5
– follow manufacturer’s
recommendation (left to right
and top to bottom and use of
wipers)
7. ENVIRONMENTAL MONITORING
USP <797> NESH
1. Temperature
2. Surface sampling
3. Pressure and velocity
4. Particles
5. Viable Monitoring
1. Temperature: Recorded daily –
in compliance.
2. Others: N/A
9. AMPULS, SINGLE-DOSE AND MULTIPLE-DOSE
CONTAINERS
USP <797> Classification NESH
1. Single dose-containers – intended
for one use (include bags, bottles,
syringes, ampules and vials) and
may not be saved or used at anytime
during the compounding process and
5microns filter straws or needles
must be used when withdrawing
contents from ampules.
2. Pharmacy bulk packages
3. Multiple-dose vials – may be
reused or saved up to manufacturer’s
recommend BUD or max of 28 days
for reuse or saved and must be noted
if intended to reuse.
1. Single dose-containers: In
compliance.
2. Pharmacy bulk packages: N/A
3. Multiple-dose vials: Never reuse
or save.
10. PERSONNEL RESPONSIBILITIES
USP <797> Requirements NESH
1. Hygiene and Garbing
• Before entering compounding area, all personnel must remove
personal outer garments, all cosmetics and jewelry. No nail polish
and natural nails should be kept trimmed and neat.
• Garbing procedures:
o Shoe covers hair covers face mask.
o Hand wash: remove debris from under fingernails using
running warm water and a nail cleaner wash hands
then forearms to the elbows with soap and water for at
least 30s dry hands and forearms using an electronic
hand dryer or lint-free disposable towels.
o Non-shedding gowns waterless alcohol scrub
powder-free gloves and disinfect the gloves with 70%
alcohol.
2. Compounding Procedures
• Periodically disinfecting gloves with 70% alcohol
• The gowns can be reused during the workshift only and must be
hung inside-out. Shoes, hair cover and mask cannot be reused.
• All hand hygiene and garbing must be followed upon returning to
compounding area.
3. Cytotoxic and other hazardous agents (OSHA
requirements)
4. Specialty Preparations
5. Compounding Competency
• Low and medium risk operations: training and competency
assessments are required initially upon hiring or transferring to
compounding responsibilities.
• And periodically every 12 months for all staffs involved.
• Includes: Media-fill testing and glove fingertip testing.
1. Hygiene and Garbing – in
compliance.
2. Compounding Procedures – in
compliance.
3. Cytotoxic and other hazardous
agents – N/A.
4. Specialty Preparations – N/A.
5. Compounding competency – in
compliance .
11. PACKAGING AND LABELING
USP <797> Requirements NESH
All risk level CSP should contain at least
the following information:
1. All solution, drug and ingredient
names, amounts, strengths and
concentrations, and the total volume
of CSP.
2. BUD and time.
3. Appropriate auxiliary labeling.
4. Any storage requirements, if CSP will
not be immediately administered.
5. Device-specific instruction (if
applicable).
6. Identification of individual
responsible for checking CSP (e.g.
pharmacist initial).
In compliance.
Note: BUD is only for 12 hours.
12. STANDARD OPERATIONAL PROCEDURES (SOPS)
USP <797> NESH
• Lists and recommends SOPs and
should be reviewed to guide the
pharmacy department in
developing, writing and
implementing SOPs.
• SOPs are part of a good quality
assurance program within the
pharmacy.
• Cleaning and garbing procedures
that are updated every year.
• Quality Assurance Program is
online and all staffs involved are
required to review every year.
13. PHARMACY PERSONNEL RESPONSIBILITIES
PHARMACISTS PHARMACY TECHNICIANS
• Follow NESH’s SOPs:
1. Inspection and Verification of
CSPs including checking correct
ingredients, quantity and quality,
labels, BUDs, calculations.
2. Preparation of immediate-use
CSPs.
3. Competency: Media-fill Test &
Gloved Fingertip Sampling
(annually).
• Regularly update with current USP
and IV compounding
regulations/requirements.
• Oversee all the compounding
activities.
• Assigned pharmacist(s) should
also be responsible for IV training
of new technicians.
• Follow NESH’s SOPs:
1. Gowning and Garbing.
2. Maintaining and Cleaning IV room.
3. Compounding techniques
(including review of calculations).
4. Temperature control.
5. Competency: Media-fill Test &
Gloved Fingertip Sampling
(annually).
Laminar Airflow Workbench functions in a similar manner as Compounding Aseptic Isolator, but the difference is CAI is a closed system and the compounding area does not interact with airflow.
For horizontal airflow never allow anything to pass behind a sterile object
For vertical airflow (Microsphere IsoTech) never allow anything to pass above a sterile object
For non-hazardous compound LAFW and/or CAI
For hazardous compound BSC and CACI
Buffer area: water sources, sinks or floor drains are not permitted in the buffer area or not immediately adjacent to.
Requirement for buffer area: air supply: HEPA filtration (room), room pressurization, perforated plate or swirl air diffuser if necessary.
ACD = accurately combine drugs and solutions into single delivery container and most commonly used for TPNs