Material types Flashcards
Critical points in glass manufacture
Furnace controls
Raw material quality
Quality of tooling
Removal of lubricants from outside of glass
Control of lubricants to ensure no entry into glass
Lehr temperature control
Maintaining cleanliness of glass after manufacture – clean area fed with filtered air
Containers normally pyrogen free and sterile
IPCs – use ‘go/no-go’ gauges for dimension checks
Glass for use in non-sterile products: Glass cleaned of debris but not normally washed
Glass for use in sterile products: Glass washed with high quality water.
Glass
Addition of soda (Na2CO3) reduces softening point but a high sodium content lowers chemical resistance susceptible to degradation
Addition of lime improves chemical resistance
Borosilicate glass has improved thermal resistance
Hydrolytic resistance (chemical resistance) pharmacopoeial test. Type I will pass, Type II will fail.
Moulded Bottles: Raw materials mixed and fed into furnace to make molten glass
Final form made in 2 stages:
Molten glass transferred to hollow tube (parison) where a rough shape is formed.
Mould closes and parison held in position. Compressed air blown into parison which inflates the molten glass and fills mould. Glass removed from mould.
Tubular Glass Containers (ampoules/vials): Long string of glass is cut/broken and shaped using heat.
Final form passes through annealing lehr Process of slowly cooling glass to relieve internal stresses. If glass cooled too quickly gets stressed & more likely to break. Also removes dust/particulates on surface.
Plastic manufacture
Extrusion
Moulding
Packaging Cpt Testing:
Appearance
Identity of contact cpts (IR)
Dimensions
Artwork
Colour (Pantone)
Micro may be required for sterile cpts
Extractables & Leachables (not routine)
Container closure systems:
Critical part of CTD
Extent of data to inc. depends on use/dosage form/route of admin
Submission inc. description/suitability/QC control
Primary cpts – Materials of construction, specs (dimension/drawing)
Secondary components – Brief details
EMA guidelines for plastic primary packaging materials (API and FP)
Defines info required for dossier/testing based on product type
Decision tree on docs required for material based on product type
EP monographs on materials used for containers / on containers (3.1 & 3.2)
Ph. Eur. 3.2.2: Plastic containers and closures for pharmaceutical use
Must provide protection, compatible, safe (ext/leach) & functional
Typical Packaging Materials for Blister:
Base material: Blister laminate material
Forms blister pockets
PVC most basic as is easy to form and seal
Robust and provides product protection
PVDC may be added to provide extra protection
Alu laminate layer may be used for moisture sensitive products
Blister lidding material
Typically aluminium lidding foil
Seals product in blister, protects from moisture / oxygen
Standard thickness 20um
Impermeable at thicknesses >25um
May need coating/laquer to prevent reaction with product
Carton
Protects from physical damage and light
Local country requirements printed on carton
Suitability established in development - and selected based on product properties such as moisture or light sensitivity
Extractables
Chemicals released from packaging system/components into extraction solvent(s) under lab conditions. Lab studies may accelerate normal conditions of storage & use. Have potential to leach into a product under normal conditions of use.
Leachables
Chemicals that make their way into product under normal product conditions/storage/application. May be classified as extractables subset
Outer packaging labelling (Title V, Art. 54) – 14 items
Name inc. strength and form
API name with amount per dose (e.g. Perampanel 2mg)
Form and contents by number of doses (e.g. tablets x28)
List of excipients with recognised effect, for injectables/topicals/eye preparations all excipients must be listed
Method and route of administration
Special warning to store out of reach and sight of children
Special warning if necessary for product type
Storage conditions
Disposal precautions if necessary
Name and address of MAH
Authorisation number
Batch number
Expiry date
Safety Features (Unique identifier & TE)
(Non POM: Instructions for use)
May also have local requirements in ‘blue box’, e.g. price
Must comply with QRD Template (Quality Regulatory Document)
Variations to change labelling – New indication/SAFETY MONITORING
Storage of printed cpts NB – must be secure and appropriate temp/RH
Braille
Name of product must be on packaging in braille format.
Directive 2004/27
Gdl on readability of labelling & package leaflet of medicinal products
