2019 1.01.2019 Historic milestones Company developments Companys - - PowerPoint PPT Presentation

COMPANY PROFILE 2019

1.01.2019

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Historic milestones 1950 2000 2010

Established in 1950 as producer of Christmas decorations Began production of medical vials Piramida produces 70 million ampoules and vials while employing 80 people Surge of sales: from 80m ampoules in 2002 to 341m in 2010 Modernization and enlargement of production capacities including introduction

• f clean rooms

Blue Sea Capital acquires Piramida in 2012 Lean and agile manufacturing strategy implemented Increase in sales and production capacity to 10 MEUR and 550m ampoules and vials in 2018

Company developments

Pharmaceutical companies in Zagreb region Pharmaceuticals in western part of ex Yugoslavia (Croatia and Slovenia) With continuous capex and production capacity expansion, Piramida targets pharma multinationals, both originator and generic companies as well as contract manufacturers. Long standing partners and clients include: Fresenius Kabi, Novartis, Teva, Mylan, Krka, Takeda, Sun Pharma, Stada and HBM Piramida re-establishes sales with pharmaceuticals from Serbia and other former Yugoslav republics Expands its sales network to the greater EU region, as well as other markets including CIS countries and the Middle East

Company’s markets

2016 new vial production line acquired 2017 and 2018 two new ampoule production lines installed

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Piramida Today

Piramida is one of the leading European suppliers of primary packaging made from Type I tubular glass to the pharmaceutical and cosmetics industry. With more than 65 years experience in production of premium quality ampoules and vials, we offer high end, high quality solutions to our customers and partners. Manufacturing is organized according to cGMP standards and adheres to Lean principles on 19 production lines with annual capacities of:

• 510.000.000 ampoules
• 35.000.000 vials

Packaging is organized in Clean Rooms that meet the requirements of ISO 14644-1 class ISO 8.

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Piramida Manufacturing - commitment to quality and continuous improvement

Two state of the art production facilities adhering to cGMP standards and optimized for lean production.

Ampoules production:

• Seventeen ampoule lines manufactured by

Moderne Mechanique Vials production:

• ne Ambeg vial RP-1 line (with two forming

machines) and one vial line manufactured by S.P.A.M.I. Glass tubes suppliers (clear or amber):

➢ SCHOTT Rohrglas GmbH ➢ Corning (ex Gerresheimer) ➢ Nipro (France) ➢ NEG

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Product range

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Ampoules

• Production capacity is appx. 1.450.000

pieces/day

• Capacity: 1 - 25 ml.
• Fully automated production lines
• B, C, and D forms available according to

ISO 9187 or to custom configurations and dimensions

– OPC (one-point-cut) – CBR (color-break) – With or without code rings – With or without print

• All 17 production lines are equipped with

dimensional and cosmetic camera inspection

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Vials

• Production capacity is appx. 110.000

pieces/day

• Capacity: 2 - 35 ml.
• Fully automated production lines
• Standard ISO 8362-1 as well as custom

configurations available

• Features available:

– Blowback

• Tablet

– Screw

• Groove

– Injection

• With fit

– Lyophilized vials (optimized bottom concavity).

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High Tech and Innovative Visual Inspection Systems Cameras are installed on ampoule and vial production lines. Features include:

• Set-up of nominal values and tolerance range
• Measurement of 9 different dimensions
• Control of up to 30 cosmetic features of the

product

• Automatic rejection of out-of-specification

products

• Real time reporting to the operator
• Other key functions:

‒ Print control ‒ automatic adjustment of dimension “d4” – stem diameter ‒ eccentricity (circular run out) control

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Quality Control and Assurance

Quality control of products is performed continuously by highly trained and educated employees in order to insure the highest standards of quality.

• Layers of Quality control:
• 1. Control of product in the clean room

➢ Visual and dimensional control

• 2. Control of product in chemical and physical laboratory

➢ dimensional control ➢ measurement of wall thicknesses with the digital gauge (w1), residual stress test ➢ eccentricity, breaking force measurement and ➢ testing of hydrolytic resistance

3. Final control

➢ Proof of all above mentioned controls according to ISO 2859-1

Our Quality Assurance System is certified by Norwegian company, DNV

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Quality systems

✓ ISO 9001:2015 ✓ ISO 14001:2015 ✓ ISO 15378:2017 ✓ Clean Rooms ISO 14644 class 8 ✓ US DMF 25150 ✓ Canada DMF:2013-208

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Market and Customers

• 3rd biggest supplier of ampoules in

EU

• Supplier for many top 10 world

generic companies

• Supplier for top originator companies
• 40+ leading pharmaceutical

customers in 17 different countries

• Our customers:

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Why Piramida should be your ampoule and vials supplier

1. 60 years experience in production of ampoules and vials for the pharmaceutical industry 2. Quality that exceeds standards 3. Flexible and responsive 4. Problem solving and customer focused 5. Efficient and Competitive

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Piramida Tomorrow

• Continue to be a trusted partner to the European pharma and

healthcare industry

• Grow globally based on leadership position in product quality and

responsiveness to customers needs

• Innovate in all business areas with focus on technology, quality,

people management and customer satisfaction

• Maintain steady investment in capacity and technology and continue

stable double digit growth in both ampoules and vials business

• Extend benefits from Lean management and continuous improvement

culture to our customers