Post on 23-Jan-2015
description
Sheffield Pharmaceuticals
Adaptable · Integrated · Scalable
Providing Value Chain Solutions for the OTC Health Care and Personal Care Markets
We are a company of committed, team-oriented professionals focused on providing the highest quality service and products to our customers in accordance with FDA cGMP regulations and procedures
Jennifer Noonan Sheffield PPT
Background and History
Founded by Dr. W.W. Sheffield, inventor of crème dentifrice and tubed toothpaste
159 years continuous operation in CT Historic Landmark-designated location
Core focus on OTC pharmaceutical and HBA preparations
Purchased by Faria family in 1986
20+ years pharmaceutical development and manufacturing
150 employees, average tenure 5+ years
Jennifer Noonan Sheffield PPT
The Total Value Chain Solution
Turnkey CMO Delivering Project Management and Support
Quality Assurance and Regulatory Guidance
Quality Control, Stability, and Production
Research & Development Laboratory
Graphics Department Offering Development and Compliance Review
Purchasing Department for International Best-Cost Sourcing
Jennifer Noonan Sheffield PPT
Production Specialization
Offering Customized Manufacturing Solutions
Compounding in Continuous-Improvement Suites
On-site Machine Shop for Custom Tooling
100% Off-Grid Uninterrupted Power Supply
Manufacturing on Customizable On-demand Filling Lines
Jennifer Noonan Sheffield PPT
Prime Vendor Capabilities
Partnering with distributors to reduce touch-points and carry-through
Single-market focus specializing in topical OTC and Apothecary formulations
Jennifer Noonan Sheffield PPT
Triple AntibioticTriple Antibiotic with Pramoxine
BacitracinDiphenhydramine
HydrocortisoneMenthol Muscle Rub
Capsaicin Muscle RubZinc Oxide
Hemorrhoid ReliefClotrimazole
Povidone IodineTolnaftate
Benzoyl PeroxidePetrolatum with A&D
Personal LubricantWarming Lubricant
Fluoride ToothpastesWhitening Gels
Denture AdhesivesBaby teething Gel
Adult Oral Gel
Contract Packaging Manufacturer
Turnkey Product Solutions from R&D to Full-scale Production
Staffed by industry veterans, from custom-machining to unique filling options, we will meet your development and production needs
Relying heavily on team communication, Sheffield’s Matrixed Project Management platform assures continuity and immediate response
Scientific methods and experience join with responsiveness and innovation to provide support from inception to final delivery
Jennifer Noonan Sheffield PPT
Outsource Management
Adaptability Our industry professionals can jump in at any point of your product’s
development cycle - From ideation and bench top development, through pilot and accelerated
stability studies, Sheffield adds value and delivers.
Consistency The average tenure of our professional staff is 6+ years, with degrees in
Industrial and Organic Chemistry, Microbiology and Clinical medical degrees, and
specializations in cosmetic chemistry, clinical testing, and compliance, Sheffield is a
dependable, partner for years to come.
Flexibility Proprietary product development, validated method development, stability, Phase
I-III compounding and manufacturing, bulk and finished goods, Sheffield will work to
custom-tailor our capabilities to your project requirements.
Jennifer Noonan Sheffield PPT
Quality Control30 professionals and chemists degreed in Industrial, Cosmetic, and Organic Chemistry
In-house services include
Process, Product, and Packaging Validations
Equipment IQ, OQ, PQ testing
Blend uniformity
Validated Methods for Phase I-III manufacturing
Stability testing and assessment
USP micro limit testing for raws and finished products
Analytical services for raws and finished products
Compatibility testing
Chromatography
USP Antibiotic testing
Jennifer Noonan Sheffield PPT
Compliance and Regulatory Affairs
Sheffield’s QA Department develops and refines cGMP practices, guiding customers through monograph and compliance standards.
Annual STR Laboratories Gold Star Certification
QA Continuous Improvement programs,
with bi-annual procedural review
Regulatory FDA/ICH guidance
Monograph compliance strategies
Formulation development
Export documentation to 80+ countries
Jennifer Noonan Sheffield PPT
Research and Development
The primary scientist assigned will see your project through to completion
Formulation development
Bench and prototype sampling
Pilot to small scale commercial batching
Reverse engineering
Regulatory monograph guidance
Jennifer Noonan Sheffield PPT
Compounding Overview
Climate-controlled 200 ton capacity raw materials storage
10,000 gallon sorbitol, glycerin and petrolatum tanks on site
12,000 liter stainless steel deionized water holding tank
Environmentally controlled, self-contained compounding suites
800 liter mixers with heating/cooling: 10° to 100°C
7 – Compounding fill lines
5 - Nauta mixers
2 - Blade stator mixing tanks
6-Versators, 50 l/m capacity
Jennifer Noonan Sheffield PPT
Manufacturing Capabilities
3-Collapsible Tube Filling TGM Machines
13mm to 50mm diameter and 50mm to 200mm length
Dosing from 10ml to 200ml
Heated / chilled product hoppers
2- High Speed Comadis CD180 Fillers
Aluminum, laminate, polythene and polyfoil tubes
Bottle and Jar Filling
Dosing from 25 to 540ml
Induction sealing/automatic capping
Packet Filling
Dosing from 1-28ml
Custom Case Labeling
Display, Inner Case, Gift Pack
Jennifer Noonan Sheffield PPT
Product Customization
Deliveringa Catalog of Formulations
and Current SKU’s
Jennifer Noonan Sheffield PPT
Supply Chain / Logistics
Monthly S&OP calls to review results and opportunities
Dedicated project manager to support customer and production teams
Complex global supply chain management experience
Procurement specialists to source chemicals & components
Aggressive cost improvement programs
Regular “Key Supplier” business reviews
Jennifer Noonan Sheffield PPT
Green Initiatives
Facility-wide motion-activated fluorescent lighting
Dedicated recycling program for waste paper, cardboard and discontinued components
First manufacturing facility in US to approach NPA for process certification
Reducing waste thru electronic posting of inter-company information
4-day factory week to limit energy consumption and commuting
Smoke-free facility
Jennifer Noonan Sheffield PPT
Sustainability
Sustainability Product Index and Eco-label Plan co-packager
100% off-grid energy co-generation
Developing energy cost, plant emission, material sourcing
Partnering to establish global social compliance matrices
Thermal capture to generate hot water and facility heating
Dedicated recycling program for waste paper,
cardboard and discontinued components
Jennifer Noonan Sheffield PPT
Summary
Sheffield Pharmaceuticals is a leader in the development of topical API and cosmetic formulations.
Total turnkey services including formulation development, GMP manufacturing, analytical methods
development, stability testing, manufacturing, and shipping.
We provide world-class technical support, source the highest quality components, and employ the
most efficient use of time and materials to control costs.
Total solution to your development, design, and manufacturing, needs.
Custom-tailored project management for rapid delivery, high quality, best-cost models.
Jennifer Noonan Sheffield PPT