new product introduction - cphi online · • fmea risk assessments (failure mode and effect...
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PHARMACEUTICAL DEVELOPMENT
Our NPI department brings valuable expertise, helping our clients from early stage development (up to phase III) to scale up and full commercial manufacturing and packaging.
NEW PRODUCT INTRODUCTION
• Delivery of cGMP & non-cGMP prototypes
• Small scale production / Small API needs
• High quality prototyping: rapid screening of
formulation options
• Anticipation of potential up-scaling issues:
Early characterization of powders
• Specific equipments: STYL’One compaction
simulator and Procept
FULL DEVELOPMENT PROGRAMNew Product Introduction Department
EARLY STAGE PROGRAM
SCALE-UP & QUALITY BY DESIGN PROGRAMS
TECH TRANSFER
• FMEA risk assessments (Failure Mode and Effect Analysis)
• FTA risk assessments (Fault Tree Analysis)
• DOE (Design of Equipment)
• Statistical data treatment with Minitab software
• Use of STYL’One Evolution equipment to allow effective
QbD with small amount of raw materials & APIs
• Derisked scale-up to commercial scale manufacturing
• Equipment qualification and process validation
QUALITY BY DESIGN
Skyepharma has a proven history of successful technology
transfers at all phases, with professional project
management, technical, and operational expertise to
support even the most complex transfer requirements.
Our qualified and highly-skilled team are exposed tointernational quality standards and experienced atmanufacturing for third-party customers. They will supportyou at every stage during technology transfers.
We are committed to bringing value to your project by
giving you strategic and financial advantage and
accelerating time-to-market.
ORAL SOLID DOSAGE FORMS
We are specialists in development and manufacturing of classic and complex oral solid dosage forms :
Single-layer tablets Multi-layer tablets
Tab-in-tab Tab-in-caps
STATE-OF-THE-ART EQUIPMENT
Unique single-layer, multi-layer, tab-in-tab, tab-in-caps,
industrial press park available.
A development methodology which focuses on
effective drug development. It is a systemic and
dynamic approach that assumes that quality is built in
by design and is continuously improved.
With critical parameters identified, it aims to more
effectively explore the characteristics of molecules in
order to better master the manufacturing process.
ANALYTICAL SERVICES
From development to commercial production phases, we
prioritize agility, expertise and quality.
LABORATORY EQUIPMENTS
• Bioburden tests (EP 2.6.12-13 / USP<61>)• Filtration method• Vitek® → Germs identification • Autoclave (250 L capacity)
MICROBIOLOGY
SAMPLING AREA
• Stability chambers• High capacity (19 chambers)• ICH conditions (25/60; 30/65; 40/75; 30/75; etc)• Refrigerated cond.• Freezer
IDENTIFICATION CHARACTERIZATION & ANALYSIS
• Centrifugation for heat-sensitive products• Surface area and pore size analyzer (BET)• Friability, disintegration, viscosimetry, etc• Brookfield viscosimeter• UV-Visible spectrophotometer (Perkin Elmer)• IR/NIR spectrophotometer (Perkin Elmer)• Karl Fisher (Mettler)• Potentiometry• Pycnometry• Particle Size Analysis by Laser Diffraction
(Malvern)• Total Organic Carbon (TOC)• HPLC : PDA multi-wavelength detector, UV
detector, Refractometer• GC : FID é TCD detectors, Headspace, Gas valve • On and offline dissolution (SOTAX)
QUALITY CONTROL
Our dedicated team ensure the compliance of each excipient or API until the finished product is developed.
Entire analyzes are made according to applicable pharmacopoeias or internal monograph.
• Microbiological and chemical testing of raw materials, IPC and finished product
• Handling and analysis of controlled substances• Handling and analysis of light-sensitive products• Regulatory and documentation upgrade
ANALYTICAL DEVELOPMENT
Product development is closely supported by a highly-experienced team during every phase of thedevelopment process.
• Analytical method development and validation• Analytical method transfer• Process optimization• Registration and commercial stability studies• Qualification of second standards handling for
light-sensitive compounds• Cleaning method development and validation
TEAM FOR YOUR PRODUCT1The analytical team supports our clients during every phase of the development process.
MICROFLUIDIZERT M TECHNOLOGY
The liquid solution or suspension passes through micro-channel(s) and is
subjected to extremely high shear and impact forces to achieve uniform
particle size reduction.
The use of exclusive fixed-geometry interaction chamber and unique way
of scaling up through parallelizing multiple micro-channels guarantee the
process scalability.
M I C R O F L U I D I Z E R T M * T E C H N O L O G Y
BENEFICIAL PHYSICO-CHEMICAL ATTRIBUTES
• Micrometer to submicrometer particle size
• Narrow particle size distribution
ENHANCED BIOAVAILABILITY OF BCS II AND IV COMPOUNDS
• Faster onset of action
• Reduced PK and fed/fasting variability
• Improved dose proportionality
• High drug loading
• GMP• Approx. 15 L / min• Cooling and dagazing
equipment included
High shear zones of Skyepharma commercial production unit
High PressureInlet P1
High ShearZones
High ImpactZone
Low Pressure Outlet P2
* Technology owned by
The obtained liquid solution or suspension is then dried to remove the solvents and produce the dried particulate
system to be further compressed.
MicrofluidizerTM Technology is also of great interest for the ma,ufacture of nano and micro emulsions.
Skyepharma expertise in bioavailability enhancement for oral solid dosage forms.
bef
ore
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Skyepharma commercial Microfluidizerproduction unit
PACKAGING SERVICES
BOTTLE LINEAble to fill any kind of bottle with tablets and capsule.
PRIMARY PACKAGING (ISO 8)
• Plastic and glass bottles loading station• Blowing station with clean air• Tablets and capsules Hopper• Visual Counting Station with 4 inspection
cameras.• Weighing cells before and after the filler head• Cottoning station• Caping station (all king of caps)
SECONDARY PACKAGING
• Horizontal Cartoner• Track&Trace and labelling machine (Tamper Evidence)• Automatic horizontal casepacker including aggregation
camera and labeler• Manual paletization and aggregation of the shipper case
on the palet.
Able to fill any kind of tablets, capsules, in all kind of blisters.
BLISTER LINE
BRAND NEW LINES
SECONDARY PACKAGING
• Inductive sealer• Rotary labelling machine including variable data printing
and OCR • Horizontal Cartoner• Track&Trace and labelling machine (Tamper Evidence)• Automatic horizontal casepacker including aggregation
camera and labeler• Manual paletization and aggregation of the shipper case
on the palet.
PRIMARY PACKAGING (ISO 8)
• Forming Station for both PVCs and aluminium• All kind of feeder for tablets and capsules
The numbered cartons are linked to the shipper cases and finally to the pallets.
• Printing of the shipper case label.• Printing of the pallet label.• Control of labels• Association of cartons and shipper cases• Shipper cases/pallet aggregation
Authentication on the carton.
• Provision of serial numbers.• Printing• Verification• The data are commissioned
SERIALIZATION AGGREGATION
ROUND AND SQUARED BOTTLESUp to 75 bottles per minutes
• Capacity• Caps’s width
• Bottle height• Bottle width
18 to 90 mm
7 to 50 mm
15 to 1000 ml
35 to 180 mm
BLISTERUp to 210 blisters and cartons per minutes
• Depth• Blister lenght
• Blister width
70 to 140 mm
30 to 86 mm
Up to 12 mm
PVC-PVDC-ACLAR-TRIPLEX / AluAlu / Alu
• Materials
• Bottle and Blister• Bottle
Height : 15 to 90 mmLengh : 55 to 250 mmWidth : 20 to 120 mm
• Bottle
Height : 15 to 90 mmLengh : 75 to 150 mmWidth : 35 to 90 mm
Height : 110 to 350 mmLengh : 140 to 520 mmWidth : 120 to 400 mm
CARTON SHIPPER CASE