PET Power is a leading specialist in PET packaging for the healthcare industry. They have a quality management system certified to ISO 9001:2008 and cGMP standards. Products are manufactured in a cleanroom facility classified as ISO Class 7 and Class 8. Quality control testing is performed on all products, including 100% leak testing. Traceability is ensured through a labeling system that tracks production details. Optional gamma irradiation is used to sterilize products upon customer request.
FACTORS IN THE DESIGN OF PARENTERAL PRODUCTION FACILITIESNEHA SINGH
THIS PRESENTATION DESCRIBE ABOUT DIFFERENT FACTORS RELATED TO PARENTERAL PREPARATION OR PRODUCTION MAINLY AND HAVE DIFFERENT SPECIAL TERMS RELATED TO PARENTERAL DEPARTMENT ,BENEFECIAL FOR THE PHARMACY STUDENTS BOTH B.PHARM OR M.PHARM OR BIOTECHNOLOGY MAINLY
FACTORS IN THE DESIGN OF PARENTERAL PRODUCTION FACILITIESNEHA SINGH
THIS PRESENTATION DESCRIBE ABOUT DIFFERENT FACTORS RELATED TO PARENTERAL PREPARATION OR PRODUCTION MAINLY AND HAVE DIFFERENT SPECIAL TERMS RELATED TO PARENTERAL DEPARTMENT ,BENEFECIAL FOR THE PHARMACY STUDENTS BOTH B.PHARM OR M.PHARM OR BIOTECHNOLOGY MAINLY
Aseptic process tech & advanced sterile product mfg rashmi nasareRASHMINasare
Aseptic process technology & advanced sterile product manufacturing technology it is done for doing in process quality control test for sterile product
STANDARD OPERATING PROCEDURES FOR PARENTERAL DOSAGE FORM PREPARATIONAVIJIT BAKSHI
PRESENTATION CONTAINS THE INFORMATION ABOUT STANDARD OPERATING PROCEDURES FOR PARENTERAL DOSAGE FORM PREPARATION FOLLOWED BY PHARMACEUTICAL MANUFACTURING COMPANIES.
Appreciated by customers across the nation for supplying, trading and wholesaling a broad array of high quality pharmaceutical hygiene & cleanRoom
products, June Enterprises started its operations in December 2013.
In a short span of time, the company expanded its breadth of operations to provide CleanRoom Products to the Indian pharmaceutical industry &
neighboring countries.
The product range offered by June Enterprises includes: – Sterilization Monitoring & Validation Products, ATCC Culture, Cleanroom Garments &
Accessories, Cleanroom Supplies, Critical Cleaning Products, Products for Food & Facilities, Sterilization Packaging & Sealing Products, Products for
Stores & Warehouses, USP Class Silicone Tubing among others.
In order to ensure high standards of quality, the offered range of Cleanroom Products is procured and sourced from trusted and reliable Leaders in their
® ® respective product ranges for example Sterilization Products by Mesa Labs, Cleaning & disinfectants by Contec & ATCC by Microbiologics.
With years of experience, expertise and a proven track-record of helping many companies with its CleanRoom Products & Sterilization needs, June
Enterprises has established an enviable position in the PHARMA, FOOD & HOSPITAL segments.
JUNE Enterprises is an ISO 9001:2015 certified company.
Learn More: https://www.juneenterprises.com/
Hahnemühle‘s Albet LabScience brand is a range of products designed for general filtration applications and complex filtration processes in life science and analytical applications in chemical and biological laboratories. The technical specifications of our membranes and syringe filters allow their use in areas where reproducibility and consistency are of major importance.
Quality
Our syringe filters undergo strict quality controls during and after production. The storage life of the finished products in the
warehouse is constantly monitored. Each filter holder undergoes the following five tests: bubble point, burst pressure, membrane absorption, flow rate and extractable substances. The range includes filter holders for the reliable separation of microorganisms and particles in liquids, air and other gases. Clear and sterile filtration, sample production, sterile aeration and medical applications are just some of the areas where disposable filter holders are typically used. They are available in different pore sizes and with different hydrophilic or hydrophobic membrane materials.
Our microfiltration range also includes membrane units. The first step towards successful analysis is choosing the right membrane unit. We offer you different membrane filters with pore sizes from 0.2 μm – 8 μm for particle removal or for the collection of the microorganisms to be examined from solutions. Various cellulose-based membranes and polymer materials cover a wide range of application areas, from clarification and sample preparation to sterile and air filtration to aeration and microbiological control. See our quick and easy to use guidelines on page 8f, which will help you to decide which product is perfect for you.
We are manufacturers of plant growth chambers in India
since last two decades. Our plant growth chamber rare
conceptualized and designed to create test chambers to
study and contemplate the effects of different environmental
parameters such as humidity, temperature and light in
various applications tests involving micro-organisms,
plants, tissues, and animals etc apart from various
customized industrial and research applications.
Our plant growth chambers have a variety of usage in R & D
laboratories and research studies across the globe. Apart
from that, these plant growth chamber have a variety of
usages in tissue culture applications, enzyme reaction
studies, growth observation studies, fermentation analysis
and Various other general and specialized applications in
various laboratories.
Aseptic process tech & advanced sterile product mfg rashmi nasareRASHMINasare
Aseptic process technology & advanced sterile product manufacturing technology it is done for doing in process quality control test for sterile product
STANDARD OPERATING PROCEDURES FOR PARENTERAL DOSAGE FORM PREPARATIONAVIJIT BAKSHI
PRESENTATION CONTAINS THE INFORMATION ABOUT STANDARD OPERATING PROCEDURES FOR PARENTERAL DOSAGE FORM PREPARATION FOLLOWED BY PHARMACEUTICAL MANUFACTURING COMPANIES.
Appreciated by customers across the nation for supplying, trading and wholesaling a broad array of high quality pharmaceutical hygiene & cleanRoom
products, June Enterprises started its operations in December 2013.
In a short span of time, the company expanded its breadth of operations to provide CleanRoom Products to the Indian pharmaceutical industry &
neighboring countries.
The product range offered by June Enterprises includes: – Sterilization Monitoring & Validation Products, ATCC Culture, Cleanroom Garments &
Accessories, Cleanroom Supplies, Critical Cleaning Products, Products for Food & Facilities, Sterilization Packaging & Sealing Products, Products for
Stores & Warehouses, USP Class Silicone Tubing among others.
In order to ensure high standards of quality, the offered range of Cleanroom Products is procured and sourced from trusted and reliable Leaders in their
® ® respective product ranges for example Sterilization Products by Mesa Labs, Cleaning & disinfectants by Contec & ATCC by Microbiologics.
With years of experience, expertise and a proven track-record of helping many companies with its CleanRoom Products & Sterilization needs, June
Enterprises has established an enviable position in the PHARMA, FOOD & HOSPITAL segments.
JUNE Enterprises is an ISO 9001:2015 certified company.
Learn More: https://www.juneenterprises.com/
Hahnemühle‘s Albet LabScience brand is a range of products designed for general filtration applications and complex filtration processes in life science and analytical applications in chemical and biological laboratories. The technical specifications of our membranes and syringe filters allow their use in areas where reproducibility and consistency are of major importance.
Quality
Our syringe filters undergo strict quality controls during and after production. The storage life of the finished products in the
warehouse is constantly monitored. Each filter holder undergoes the following five tests: bubble point, burst pressure, membrane absorption, flow rate and extractable substances. The range includes filter holders for the reliable separation of microorganisms and particles in liquids, air and other gases. Clear and sterile filtration, sample production, sterile aeration and medical applications are just some of the areas where disposable filter holders are typically used. They are available in different pore sizes and with different hydrophilic or hydrophobic membrane materials.
Our microfiltration range also includes membrane units. The first step towards successful analysis is choosing the right membrane unit. We offer you different membrane filters with pore sizes from 0.2 μm – 8 μm for particle removal or for the collection of the microorganisms to be examined from solutions. Various cellulose-based membranes and polymer materials cover a wide range of application areas, from clarification and sample preparation to sterile and air filtration to aeration and microbiological control. See our quick and easy to use guidelines on page 8f, which will help you to decide which product is perfect for you.
We are manufacturers of plant growth chambers in India
since last two decades. Our plant growth chamber rare
conceptualized and designed to create test chambers to
study and contemplate the effects of different environmental
parameters such as humidity, temperature and light in
various applications tests involving micro-organisms,
plants, tissues, and animals etc apart from various
customized industrial and research applications.
Our plant growth chambers have a variety of usage in R & D
laboratories and research studies across the globe. Apart
from that, these plant growth chamber have a variety of
usages in tissue culture applications, enzyme reaction
studies, growth observation studies, fermentation analysis
and Various other general and specialized applications in
various laboratories.
Acmas Technologies (Pvt) Ltd.,a research laboratory equipment manufacturing company has expanded its goal to become a one-stop shop for research laboratory equipment and instrument with the recent addition of several range of new products in their online catalog.
How to Use AI to Write a High-Quality Article that Ranksminatamang0021
In the world of content creation, many AI bloggers have drifted away from their original vision, resulting in low-quality articles that search engines overlook. Don't let that happen to you! Join us to discover how to leverage AI tools effectively to craft high-quality content that not only captures your audience's attention but also ranks well on search engines.
Disclaimer: Some of the prompts mentioned here are the examples of Matt Diggity. Please use it as reference and make your own custom prompts.
5 big bets to drive growth in 2024 without one additional marketing dollar AND how to adapt to the biggest shifting eCommerce trend- AI.
1) Romance Your Customers - Retention
2) ‘Alternative’ Lead Gen - Advocacy
3) The Beautiful Basics - Conversion Rate Optimization
4) Land that Bottom Line - Profitability
5) Roll the Dice - New Business Models
Most small businesses struggle to see marketing results. In this session, we will eliminate any confusion about what to do next, solving your marketing problems so your business can thrive. You’ll learn how to create a foundational marketing OS (operating system) based on neuroscience and backed by real-world results. You’ll be taught how to develop deep customer connections, and how to have your CRM dynamically segment and sell at any stage in the customer’s journey. By the end of the session, you’ll remove confusion and chaos and replace it with clarity and confidence for long-term marketing success.
Key Takeaways:
• Uncover the power of a foundational marketing system that dynamically communicates with prospects and customers on autopilot.
• Harness neuroscience and Tribal Alignment to transform your communication strategies, turning potential clients into fans and those fans into loyal customers.
• Discover the art of automated segmentation, pinpointing your most lucrative customers and identifying the optimal moments for successful conversions.
• Streamline your business with a content production plan that eliminates guesswork, wasted time, and money.
SMM Cheap - No. 1 SMM panel in the worldsmmpanel567
Boost your social media marketing with our SMM Panel services offering SMM Cheap services! Get cost-effective services for your business and increase followers, likes, and engagement across all social media platforms. Get affordable services perfect for businesses and influencers looking to increase their social proof. See how cheap SMM strategies can help improve your social media presence and be a pro at the social media game.
When most people in the industry talk about online or digital reputation management, what they're really saying is Google search and PPC. And it's usually reactive, left dealing with the aftermath of negative information published somewhere online. That's outdated. It leaves executives, organizations and other high-profile individuals at a high risk of a digital reputation attack that spans channels and tactics. But the tools needed to safeguard against an attack are more cybersecurity-oriented than most marketing and communications professionals can manage. Business leaders Leaders grasp the importance; 83% of executives place reputation in their top five areas of risk, yet only 23% are confident in their ability to address it. To succeed in 2024 and beyond, you need to turn online reputation on its axis and think like an attacker.\
Key Takeaways:
- New framework for examining and safeguarding an online reputation
- Tools and techniques to keep you a step ahead
- Practical examples that demonstrate when to act, how to act and how to recover
Everyone knows the power of stories, but when asked to come up with them, we struggle. Either we second guess ourselves as to the story's relevance, or we just come up blank and can't think of any. Unlocking Everyday Narratives: The Power of Storytelling in Marketing will teach you how to recognize stories in the moment and to recall forgotten moments that your audience needs to hear.
Key Takeaways:
Understand Why Personal Stories Connect Better
How To Remember Forgotten Stories
How To Use Customer Experiences As Stories For Your Brand
First Things First: Building and Effective Marketing Strategy
Too many companies (and marketers) jump straight into activation planning without formalizing a marketing strategy. It may seem tedious, but analyzing the mindset of your targeted audiences and identifying the messaging points most likely to resonate with them is time well spent. That process is also a great opportunity for marketers to collaborate with sales leaders and account managers on a galvanized go-to-market approach. I’ll walk you through the methods and tools we use with our clients to ensure campaign success.
Key Takeaways:
-Recognize the critical role of strategy in marketing
-Learn our approach for building an actionable, effective marketing strategy
-Receive templates and guides for developing a marketing strategy
A.I. (artificial intelligence) platforms are popping up all the time, and many of them can and should be used to help grow your brand, increase your sales and decrease your marketing costs.In this presentation:We will review some of the best AI platforms that are available for you to use.We will interact with some of the platforms in real-time, so attendees can see how they work.We will also look at some current brands that are using AI to help them create marketing messages, saving them time and money in the process. Lastly, we will discuss the pros and cons of using AI in marketing & branding and have a lively conversation that includes comments from the audience.
Key Takeaways:
Attendees will learn about LLM platforms, like ChatGPT, and how they work, with preset examples and real time interactions with the platform. Attendees will learn about other AI platforms that are creating graphic design elements at the push of a button...pre-set examples and real-time interactions.Attendees will discuss the pros & cons of AI in marketing + branding and share their perspectives with one another. Attendees will learn about the cost savings and the time savings associated with using AI, should they choose to.
In this presentation, Danny Leibrandt explains the impact of AI on SEO and what Google has been doing about it. Learn how to take your SEO game to the next level and win over Google with his new strategy anyone can use. Get actionable steps to rank your name, your business, and your clients on Google - the right way.
Key Takeaways:
1. Real content is king
2. Find ways to show EEAT
3. Repurpose across all platforms
Mastering Local SEO for Service Businesses in the AI Era is tailored specifically for local service providers like plumbers, dentists, and others seeking to dominate their local search landscape. This session delves into leveraging AI advancements to enhance your online visibility and search rankings through the Content Factory model, designed for creating high-impact, SEO-driven content. Discover the Dollar-a-Day advertising strategy, a cost-effective approach to boost your local SEO efforts and attract more customers with minimal investment. Gain practical insights on optimizing your online presence to meet the specific needs of local service seekers, ensuring your business not only appears but stands out in local searches. This concise, action-oriented workshop is your roadmap to navigating the complexities of digital marketing in the AI age, driving more leads, conversions, and ultimately, success for your local service business.
Key Takeaways:
Embrace AI for Local SEO: Learn to harness the power of AI technologies to optimize your website and content for local search. Understand the pivotal role AI plays in analyzing search trends and consumer behavior, enabling you to tailor your SEO strategies to meet the specific demands of your target local audience. Leverage the Content Factory Model: Discover the step-by-step process of creating SEO-optimized content at scale. This approach ensures a steady stream of high-quality content that engages local customers and boosts your search rankings. Get an action guide on implementing this model, complete with templates and scheduling strategies to maintain a consistent online presence. Maximize ROI with Dollar-a-Day Advertising: Dive into the cost-effective Dollar-a-Day advertising strategy that amplifies your visibility in local searches without breaking the bank. Learn how to strategically allocate your budget across platforms to target potential local customers effectively. The session includes an action guide on setting up, monitoring, and optimizing your ad campaigns to ensure maximum impact with minimal investment.
Come learn how YOU can Animate and Illuminate the World with Generative AI's Explosive Power. Come sit in the driver's seat and learn to harness this great technology.
Monthly Social Media News Update May 2024Andy Lambert
TL;DR. These are the three themes that stood out to us over the course of last month.
1️⃣ Social media is becoming increasingly significant for brand discovery. Marketers are now understanding the impact of social and budgets are shifting accordingly.
2️⃣ Instagram’s new algorithm and latest guidance will help us maintain organic growth. Instagram continues to evolve, but Reels remains the most crucial tool for growth.
3️⃣ Collaboration will help us unlock growth. Who we work with will define how fast we grow. Meta continues to evolve their Creator Marketplace and now TikTok are beginning to push ‘collabs’ more too.
2. PET Power’s ISO 9001:2008* certification is the base for our
quality system. The structure in clear SOP’s and work
instructions is not only audited by our notified body, but also
almost weekly by our customers, amongst them world leading
pharmaceutical companies. Our systems and controls are
updated with the feedback of our valued clients. Our staff is
regularly updated through specific training. Clients see the proof
of continuous improvement during their audits, but foremost in
the constant quality and reliable service as PET Power has
agreed with its customers. For pharmaceutical packaging we
work according to cGMP. We are also BRC certified. This standard
for the food industry does offer benefits for the pharmaceutical
industry as well.
Quality
AssurancePET PowerPET Power
PET Power
packaging your brand
PET bottles and jars are widely used in the
health care industry. PET Power is the leading
specialist in PET packaging. The health care
industry is one of our target markets. We have
developed a wide range of moulds for producing
pharma specific bottles and jars. The
combination of moulds and an expanded range
of machines offers our customers solutions
fitting to their needs.
Product development is at the heart of our company. PET Power
continuously invests in the research of new materials, closures
and bottles/jars for the benefit of our clients.
Countries with
RPC offices
Quality Control
Finished products are tested on the production line and in our QC-lab. 100% of the
products are leak tested. Critical products can be tested on a 100% base with vision
systems on particles. The operators perform visual inspection on a regular basis
and have a clear quality responsibility. The laboratory receives during production
samples from all cavities with a fixed frequency. The parameters which are
measured are:
• Weight
• Wall distribution
• Shape and dimensions
• Filling volume
• Top load
The samples are visually inspected for colour against reference samples and
on other visible defects. For pharmaceutical customers sample frequency and
acceptance/non acceptance of defects and AQL levels can be agreed in a
QA-agreement.
Certification
Following after process and product registration checks, each pallet with finished
product is formally released by our Quality Control department. Upon request your
order is given a Certificate of Conformity (CoC) which outlines the agreed
specifications of your order.
PET Power factsheet
• Founded: 1995
• Number of employees: more than 260
• More than 55 ISBM machines
• 7 ISBM machines in the cleanroom
• 1200 m² cleanroom (class 7, ISO 14644-1)
• More than 240 preforms
• More than 1300 different blow moulds
• Storage capacity of 20.000 pallets
• Partner of the global RPC packaging group
3. PET is an abbreviation for polyethylene terephthalate,
which is a particular kind of polyester. PET is a material
that can be easily heated and formed into packaging for
many different applications. The use of PET for
packaging has many advantages that include:
- unbreakable
- clear and transparent
- lightweight
- good barrier properties (oxygen, water vapour,
odours, carbon dioxide, UV, temperature), which
can potentially be further improved by the use
of additives
- extremely accurate dimensions
- wide range of colours and shapes
PET Power uses resins suitable for producing pharma-
ceutical primary packaging. The resin is produced in
conformity with Good Manufacturing Practice. The resin
is tested and complying to:
• European Pharmacopoeia 3.1.15
• USP 661
• USP class VI
PET Power also has a Drug Master III file.
Properties LDPE HDPE PP PET PETG Glass
Density 0,92 0,96 0,91 1,36 1,27 2,23
Gas transmission O2
* 118 73 53 1,7 9 0
Gas transmission CO2
* 1063 228 154 12 41 0
Gas transmission H2
O-vapour ** 3,3 0,8 0,8 4,7 11,4 0
Hot fill temp 104 121 127 60 71 N/A
Clarity P P P E F E
Drop impact F/G F/G F E F P
Chemical resistance F/G F/G F/G E F E
Process I/E I/E I/E S E N/A
Recycle code 4 2 5 1 1 1
01
PET
The
material
The ISBM
production
process in brief
Our production process is called Injection Stretch Blow Moulding (ISBM).
Bottles and jars are made in a single stage process. First, the raw material,
PET granulate, is pressed in a machine using a screw-shaped cylinder. If
needed, colour is added at this stage. A liquid is formed in the cylinder at a
temperature of close to 300 °C. This liquid is injected in step 1 of the
processinto the so-called pre-form mould. The neck of the bottle or jar has
repeatable and excellent precision. Great precision is needed because the
combination of bottle and closure must create a perfect seal. The preform
is made in step 2 of the process, in the blow mould section, stretched and
blown into the final shape. Stretching is done by using a pin to press the
base down from above and, at the same time, we are slowly blowing the
walls of the bottle or jar against the walls of the mould. In the third step of
the production process, the products are placed on a conveyor belt and
tested for any leakage. Every bottle or jar is filled with an overpressure of
filtered air to test for the absence of holes.
1
3
2
plunger screw/barrel
top-view single stage (ISBM)
neckring
side-view step 3: ejection productside-view step 2: stretch and blow
bottum plug
neckring
blowmouldblowmould
blow air blow air
blow air blow air
neckring
plunger screw/barrel
dryer hopper preform tool
hotrunner
side-view step1: injection
4. SAMPLES?
Ask for your
samples from
sample@petpower.eu
or www.petpower.eu
Packaging
your brand
closures
health care
12 CRC T/E Closure
18 DIN T/E Closure + Plug
12 CRC T/E Plug 18 DIN Closure + Paintbrush
18 DIN Closure + Pipet
18 DIN T/E Closure
20 SP410 Closure
28 ROPP T/E Closure
28 ROPP T/E Closure28 ROPP T/E Secured Closure
28 ROPP T/E Closure 28 ROPP T/E Closure
28 ROPP (30ml) Measuring Cup
28 ROPP (20ml) Measuring Cup
38 Hinge Closure38 SP400 Closure40 SNAP Closure
43 SP400 Media Closure
45 Hinge Closure45 SP400 Closure
45 SP400 Closure
5. RIBBED VERAL
Clear
veral
amber
1000 ml500 ml250 ml200 ml
30 ml 50 ml 150 ml100 ml 200 ml 250 ml 300 ml 500 ml 750 ml 1000 ml
150 ml
20 ml
find out
more
explore our
configurator
www.petpower.eu
also
available
in clear
also
available
in amber
SIROP
Clear
Clinch Vial
Clear
1000 ml500 ml300 ml250 ml200 ml150 ml125 ml100 ml75 ml60 ml
10 ml 20 ml 50 ml 100 ml 125 ml 200 ml 250 ml 500 ml 1000 ml
also
available
in amber
also
available
in amber
6. 125 ml
Therapy
HYGIA
ROUND
10 ml 15 ml 20 ml
125 ml600 ml 500 ml1100 ml 1000 ml
media
round/square
SCYLLA OVAL
CLEAR
150 ml 200 ml
also
available
in amber
10 ml 15 ml 20 ml 25 ml 30 ml 50 ml 100 ml
pilljar 40 m-snap
CLEAR
pilljar zéta
screw clear
60 ml 75 ml 100 ml 120 ml 150 ml 200 ml 250 ml 300 ml 400 ml 500 ml
60 ml 75 ml 100 ml 120 ml 150 ml 200 ml 250 ml 300 ml 400 ml 500 ml
pilljar zéta hinge
AMBER
50 ml 75 ml 100 ml 150 ml 250 ml 400 ml 500 ml
also
available
in amber
also
available
in amber
also
available
in clear
7. Cleanroom
production facility
PET Power operates an ISO Class 7 cleanroom. Controlling the amount of particles
in the room is the first purpose of the cleanroom production. The cleanroom has
overpressure inside. The air flowing into the cleanroom that creates the
overpressure is treated with HEPA-filters. Because the bottles are made out of
PET-resin which is melted at around 300C and injected at high pressure, the bottles
right after production, will be free of micro-organisms.
Ask for
free
samples
sample@petpower.eu
Traceability
Based on the information on each separate brickpack
label, we can fully trace production parameters like:
• Raw material, type and batch
• Production date
• Machine and mould
• Operator
Every brickpack has a unique number. The label also
specifies the PET Power article number, the number of
items per brickpack and the batch number. The
accompanying packing slip specifies all the pallet
numbers and the corresponding production date. On
pallet level we link the irradiation data to the irradiation
certificate. Treatment parameters can be traced back
and are stored for 10 years.
As soon as they run from the machine they are packed in a layer of
cleanroom quality PE-film inside the Class 7 cleanroom. The film is
hermetically sealed at 4 sides and creates a brickpack that forms a
barrier against microorganisms. Only in the short time between
production and packing, there is a slight possibility of contamination
by e.g. airborne microorganism. By keeping the amount of particles,
from which only a part are microorganisms, in the air low, we mitigate
the chance of microbial contamination. Apart from a low bioburden, a
stable bioburden numerical and species wise is necessary. For this
next to the amount of particles, temperature and air humidity are
monitored and kept stable. Probably the most important
factor are the employees. They are trained in working in
such a way that all sources of contamination are kept as
low as possible. Frequent re-training is of course part of
the cleanroom management. PET Power has placed its
ISBM machines in the cleanroom, so production is really
under cleanroom circumstances, not just the packaging!
Safe processing
All machines have their own laminar flow systems to
prevent any particles on products in the moving part of
the machine. The cleanroom is annually calibrated by an
external consultancy according ISO 14644. Adjacent to
the Cleanroom Class 7, there is a cleanroom Class 8.
The packed bottles run through an airlock to the Class 8
room where a second and third layer of cleanroom film
are put around the bottles. Both layers are sealed again
to form a perfect microbiological barrier. When the
packs of bottles are put in a pallet box, lined with an
extra PE-bag, they are ready for gamma irradiation, this
if the client requests so.
8. Irradiation
and Sterility
There is not such a thing as absolute sterility. After the production,
the products still can contain minor amounts of micro organisms. In
the medical industry a chance of less than 1 : 1.000.000 on a viable
micro organism is the standard to call a product sterile. This is
expressed as Sterility Assurance Level 10-6, abbreviated as SAL 10-6.
To guarantee this SAL level, the PET products are treated after the
production with gamma rays. This type of ionizing radiation will travel
with ease through a whole pallet of PET bottles, which means the
empty bottles can be gamma sterilized in their final packaging. This is
a great advantage. Gamma rays disrupt co-valent bonds in vital parts
of micro organisms. Rupture of both strands of the DNA of an
organism, caused by the radiation, will terminate its life processes.
We apply a minimum dose of 25 kilo Gray, or kGy. We have validated
the process and this dose will lead to the required SAL 10-6. The
validation method in use at PET Power is the VDmax method
described in the ISO 11137. More information can be obtained through
your contact as ultimately our clients carry responsibility for their
products. Co-valent bonds are not only present in DNA, they are the
building principle of polymers as well. Because of this polymers can
suffer from gamma radiation as well. The backbone of the PET
molecule has a special structure, which makes this polymer resistant
to gamma rays. Concisely, we say PET is gamma stable.
To be very sure no damage is done to the PET molecule, we cap the
maximum dose to 50 kGy. From extended literature study we know
that this is a very safe upper limit. Both dose limits minimum and
maximum are part of the gamma radiation validation process. This is
called dose mapping. Each treatment is certified. The customer
receives a certificate of gamma radiation, guaranteeing the minimum
and maximum dose.
Before launching your product you need to be sure your product is safe for the
consumer. PET Power can tell you about standard migration tests with standard
simulants/extract media. We also cooperate with renowned laboratories who can
test specific substances. Migration results are communicated directly to the
customer for further analysis and interpretation.
SAMPLES?
Ask for your
samples from
sample@petpower.eu
or www.petpower.eu
Laboratory services
Our customers are facing an increasing amount of rules, laws and industry
standards. PET Power supports their customers with laboratory services to
handle this. It concerns tests of your products for determining:
• Stability
• Sterility
• Compatibility
9. Head office
Key Account Manager health care
Guido Eijsermans
gei@petpower.eu
Sales Manager
Annette Kraan
ak@petpower.eu
Hermelijnweg 2
4877 AE Etten-Leur
The Netherlands
T 0031 (0)76 503 82 83
F 0031 (0)76 503 64 55
info@petpower.eu
sales force
PET Power Austria / Italy / CEE
Brunnergasse 1-9/Top 3, 2380 Perchtoldsdorf, Austria
Roland Cejka rc@petpower.eu
T 0043 (0)1869 5616, F 0043 (0)1865 5496
PET Power The Benelux
Hermelijnweg 2, 4877 AE Etten-Leur, The Netherlands
Annabel Nogueira an@petpower.eu
T 0031 (0)76 503 82 83, F 0031 (0)76 503 64 55
PET Power Germany / Switzerland
Dr.-Herbert-Kittel-Strasse 1, 87600 Kaufbeuren, Germany
Guido Eijsermans gei@petpower.eu
Marc Christian Pethke mcpethke@petpower.eu
T 0049 (0)8341 995 69-40, F 0049 (0)8341 995 69-42
PET Power France
12 rue de Villevert, 60300, Senlis, France
Alexandre Thibault at@petpower.eu
Julien Ha Eav jhe@petpower.eu
Audrey Vincent avi@petpower.eu
T 0033 (0)3445 32043, F 0033 (0)3446 02505
PET Power Handels GmbH Hungary
Brunnergasse 1-9/Top 3, 2380 Perchtoldsdorf, Austria
Kristof Steininger kst@petpower.eu
T 0043 (0)1869 5616, F 0043 (0)1865 5496
PET Power Handels GmbH Italy
Brunnergasse 1-9/Top 3, 2380 Perchtoldsdorf, Austria
Brigitta Cejka bc@petpower.eu
T 0043 (0)1869 5616, F 0043 (0)1865 5496
PET Power Nordics
Hermelijnweg 2, 4877 AE Etten-Leur, The Netherlands
René van Zandvoort rvz@petpower.eu
T 0031 (0)76 503 82 83, F 0031 (0)76 503 64 55
PET Power UK / Ireland
Hermelijnweg 2, 4877 AE Etten-Leur, The Netherlands
Bill Wickham wjw@petpower.eu
T 0044 7990 586 407
Pepijn Weijland pwl@petpower.eu
T 0031 (0)76 503 82 83, F 0031 (0)76 503 64 55