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KEY POINTS
The following key points are discussed:
• Container-closure integrity is a critical property of a pharmaceutical product. This attribute is especially
important for sterile products. The US Food and Drug Administration guidance has categorized container-
closure risks for common pharmaceutical products including degree of concern associated with route of
administration (highest-low) and likelihood of packaging component-dosage form interaction (high-low).
Sterile product container closure systems are described for most common sterile products including
ampoules, sterile vials, and other systems. Multiple integrity test methods including microbial immersion
test, microbial aerosol challenge, bubble test, and other methods are described.
Validation considerations for integrity tests are discussed.
INTRODUCTION
One of the main purposes of a container closure system is to protect its contents from the surrounding
environment. In the case of sterile products, this means maintaining the sterility of the product. The
container-closure system may also need to protect the product from other potentially harmful agents such
as light, moisture, and oxygen. This paper discusses container-closure integrity—maintaining the sterility of
the product plus protecting the product from moisture and oxygen. It further discusses various test
methods used to test for container-closure integrity.
The US Food and Drug Administration defines a container-closure system as the following:
“A container closure system refers to the sum of packaging components that together contain and protect
the dosage form. This includes primary packaging components and secondary packaging components, if
the latter are intended to provide additional protection to the drug product. A packaging system is equivalent
to a container closure system”
Presented by:
Andrea Simonetti
Director of Pharma
Bonfiglioli Engineeringa
a TASI GROUP Company
Manage the global pharmaceutical initiative at TASI APTI group. Design and
implement business initiatives and strategic development activities by leading and
overseeing the activities of an international team. Create synergies with other
companies and industry associations and foster positive business relationships
with clients by supporting multilateral cooperation and generating added value. In
2010 started providing educational support to US Food and Drug Administration -
Office of Pharmaceutical Science. Currently working with PDA “Technical Report
27 – Pharmaceutical Package Integrity” and Prefilled Syringes task force teams
Prepared by:
Gaetano Fiorentino
President PDA Italy
Many years of experience in the management of facilities and production of
Parenterals. Great knowledge of vision systems management software and
monitoring SCADA Expert in all process validation and new plant and
machinery.Development and realization of machines prototypes in order to
improve the quality and productivity. Continuous improvement of quality and
economic production in the crops in being and existing plants. Management
documentation and staff training. Continuously updated on new technologies and
the feasibility study on the potential for their use in the pharmaceutical
environment.
.
Container Closure Integrity & Visual Inspection
Regulations, Theory, Test Methods and Applications of
CCI Innovations including Hands-On Activities
2015 PDA Italy Conference, Workshop
10 December,| Vigarano Pieve, Italy
Via Rondona, 33 44049 Ferrara
AGENDA
09:00. Welcome and Introduction
a) Presentation of participants
b) Scope of the training
c) Agenda for the day
10:00 Technology Overview: Non Destructive Test and Inspection Methods for Parenteral
Containers
a) CCIT: Vacuum Decay, Pressure Decay, Lid Deflection, Force Decay
b) Visual Inspection: Detection of Critical, major and minor defects
c) Headspace Gas Analysis: Monitoring Oxygen + Moisture Level & Absolute Pressure in the
headspace of sterile parenteral containers
11:00 Regulatory Requirements and Pharmacopeial Updates
a) EU, US, Other Countries
12:00. Technology Detail: Each Test and Inspection Method is Detailed
a) Principle of operation
b) Industry case studies
c) Challenge tests
d) Validation approach
e) Lessons learned
13:00 Lunch Break
14:00. Hands-On:
1. Laboratory:
a) How to set-up and run off-line test and inspection systems
b) Creation of positive controls and reference standards
c) Testing and process validation
d) Practical live demonstration
15:30 Lunch Break
16:00. Hands-On:
2. Production Area:
a) Analysis of a 100% in-line Headspace Gas Analysis equipment
Container Closure Integrity & Visual Inspection
Regulations, Theory, Test Methods and Applications of
CCI Innovations including Hands-On Activities
2015 PDA Italy Conference, Workshop
2 WAYS
TO REGISTER
Container Closure Integrity & Visual Inspection
Your Contact Person is
Gaetano Fiorentino at PDA Italy
dt-fiorentino@italfarmaco.com
Elena Baccalaro at CCI Italy
elena.baccalaro@congressiefiere.com
10 December | Ferrara | Italy
1 ONLINE: https://www.pda-it.org/TR65
2
4
1 ONLINE: https://www.pda-it.org/CCI
EMAIL: elena.baccalaro@congressiefiere.com
EMAIL: dt-fiorentino@italfarmaco.com
ThisPDF-fileprovidesanautomatic
fill-in function. Your signature,
however, is needed in writing.
1Your Contact Information
Ifthisformisanupdatetoapreviouslysubmittedform,pleasecheckhere.
Mr. Ms. Dr. Nonmember
IwanttobecomeaPDAMember.
Please sendme asubscriptionform
Name(Last, First, MI)*
PDA Member IDNumber
Job Title*
Company* Department
Mailing Address
City Postal Code
Country Email *
Business Phone Fax
Substituting for
(Check only if you are substituting for a previously enrolled colleague; a nonmember substituting for member must pay the membership fee.)
Registration
No PDA membership included 3 Payment
All fees given in Euro andexcluding VAT
Conference (10December)
PDA Member
Nonmember 395
By Bank Transfer beneficiary: PDAItaly Chapter
IBAN: IT55T0103071940000002767926
BIC: PASCITMMPOG
Bank Address: BancaMontedeiPaschidiSiena,AgenziadiPoggibonsi,Loc.Salceto,95–53036
Poggibonsi(SI)
The fee includes course documentation as well as mid-session refreshments and lunch.
Excellent networking opportunities with snacks and drinks will be given. The fee does not
include the hotel accommodation. PDA Italy has secured a limited number of rooms at a
special group rate.
Group Registration Discount Register 5 colleagues for the con-
ference at the same time and receive the 5th registration free. For
more information on group discounts please contact Gaetano
Fiorentino at dt-fiorentino@italfarmaco.com Other discounts cannot
be applied.
DiscountforExhibitingCompanies Pleasemarkhereifyourcompanyisanexhibitortothiseventand
you will receive the conference ticket at the special price of 800 Euro per ticket. No further discounts are
applicablewiththisoption(asPDAMembershipDiscountorGroupTicketdiscount).Thisspecialratedoesnot
include one-year PDA membership. Date Mandatory Signature
CONFIRMATION: Transmitting your filled-in registration form constitutes a binding application for the specific event. PDA Europe will send you a confirmation including payment details. A legally binding contract is concluded
once PDA Europe has sent a written invoice by mail to you. You must have a written confirmation (including invoice) to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. Payment
must be received orguaranteed byPurchase Order or credit card details on 1st dayofevent, atthe very latest. SUBSTITUTIONS: Ifyou areunable to attend, substitutions arewelcome and can be made atanytime, including onsite
at the prevailing rate. If you are registering as a substitute attendee, please indicate this on the registration form. Changes are free of charge until prior to the start of the event. REFUNDS: Refund requests must be sent to PDA
ITALY. If your written request is received on or before 16 October 2015, you will receive a full refund minus a 150 € excl. VAT handling fee. After that time, no refund or credit requests will be approved. If you are an unpaid
registrant and do not attend the event, you are responsible for paying the registration fee. On-site registrants are not guaranteed to receive conference materials until alladvanced registered attendees receivethem.PDAItaly
worksPCI-Compliant.EVENTCANCELLATION:PDAreservestherighttomodifythematerialorspeakers/instructorswithoutnotice,ortocancelanevent. Ifanevent must be canceled, registrants will be notified byPDAassoon as
possible andwill receive afull refund. PDAwill not be responsible for airfare penalties or othercosts incurred duetocancellation. For more details,contact PDAatinfo-Italy@pda.org DOCUMENTATION: With your signature you
give complete picture usage right toPDAand allow to film your exhibition space and intervention inthe event, including the recording ofyour presentationfor videopurposes (withyourslides,voice andimage).This rightextends
alsototheuseoftheresultingimagesinfilmdocumentationforwebinarsandsimilaritemsproducedbyPDA.
www.pda-it.org/CCI
2
4 Location
Headquarters
Bonfiglioli Engineering
via Rondona, 33
44049 - Vigarano Pieve (FE)
Italy
+39 0532 715 631
+39 0532 715 625
Servizio di navetta da e per la stazione di
Bologna
Container Closure Integrity & Visual Inspection
10 December - Ferrara
MAKING IT EASIER FOR BOTH OF US
Ifuncertain aboutyour member IDnumberand/oryourmembershipstatus,call or @Mr. Gaetano Fiorentino.
+39 02 6443-3435 dt-fiorentino@italfarmaco.com
Pleasewaituntilwesendourinvoicetoyou.
It is helpful to reference our invoice numberin your bank transfer details.
Pleasenotetheregistrationandcancellationpoliciesatthebottomoftheform.
RegistrationcannotbecompletedbysendingPurchaseOrderalone.APurchaseOrderisonlyacceptedifa
complete registration form is enclosed or follows very soon.
This is particularly important if billing address and site address are different. Contact your accounting depart-
ment for correct address and company name. There could be special requirements for accounting. Changesin
the billing address (if induced by participating company) will be charged-prior to the startoftheevent.
Bank transfers are confirmed upon receipt of full payment.
Refunds to bank accounts can be done if payment had been done by bank transfer and the following details
areprovided: a) Name of your bank b) IBAN number c) Swift/BIC code
Ifaparticipantisunable to attend,substitutionsarewelcomeatanytime.Changesarefreeofchargeuntil
priortothestartoftheevent.
Tel: +39 02 6443-3435 Email: dt-fiorentino@italfarmaco.com
Tel: +39 011 2 4 4 6 9 1 5 Email: Elena.baccalaro@centrocongressiefiere.com
T HAN K YO U FOR YOUR COOPERATION!
10 For assistance contact: Elena Baccalaro Executive Manager Centro Congressi Internazionale Italy
9 For assistance contact: Gaetano Fiorentino, President PDA Italy
8 Substitutions
7 Refund/Credit Notes
6 Confirmation of your registration
5 Please state the correct billing address on the registration form
4 Purchase Orders
3 Complete and sign the event registration form
2 Do not send money in advance
1 Please include your member ID number on registration form if available/known
www.pda-it.org/CCI
Container Closure Integrity & Visual Inspection Regulations

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Container Closure Integrity & Visual Inspection Regulations

  • 1. KEY POINTS The following key points are discussed: • Container-closure integrity is a critical property of a pharmaceutical product. This attribute is especially important for sterile products. The US Food and Drug Administration guidance has categorized container- closure risks for common pharmaceutical products including degree of concern associated with route of administration (highest-low) and likelihood of packaging component-dosage form interaction (high-low). Sterile product container closure systems are described for most common sterile products including ampoules, sterile vials, and other systems. Multiple integrity test methods including microbial immersion test, microbial aerosol challenge, bubble test, and other methods are described. Validation considerations for integrity tests are discussed. INTRODUCTION One of the main purposes of a container closure system is to protect its contents from the surrounding environment. In the case of sterile products, this means maintaining the sterility of the product. The container-closure system may also need to protect the product from other potentially harmful agents such as light, moisture, and oxygen. This paper discusses container-closure integrity—maintaining the sterility of the product plus protecting the product from moisture and oxygen. It further discusses various test methods used to test for container-closure integrity. The US Food and Drug Administration defines a container-closure system as the following: “A container closure system refers to the sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product. A packaging system is equivalent to a container closure system” Presented by: Andrea Simonetti Director of Pharma Bonfiglioli Engineeringa a TASI GROUP Company Manage the global pharmaceutical initiative at TASI APTI group. Design and implement business initiatives and strategic development activities by leading and overseeing the activities of an international team. Create synergies with other companies and industry associations and foster positive business relationships with clients by supporting multilateral cooperation and generating added value. In 2010 started providing educational support to US Food and Drug Administration - Office of Pharmaceutical Science. Currently working with PDA “Technical Report 27 – Pharmaceutical Package Integrity” and Prefilled Syringes task force teams Prepared by: Gaetano Fiorentino President PDA Italy Many years of experience in the management of facilities and production of Parenterals. Great knowledge of vision systems management software and monitoring SCADA Expert in all process validation and new plant and machinery.Development and realization of machines prototypes in order to improve the quality and productivity. Continuous improvement of quality and economic production in the crops in being and existing plants. Management documentation and staff training. Continuously updated on new technologies and the feasibility study on the potential for their use in the pharmaceutical environment. . Container Closure Integrity & Visual Inspection Regulations, Theory, Test Methods and Applications of CCI Innovations including Hands-On Activities 2015 PDA Italy Conference, Workshop 10 December,| Vigarano Pieve, Italy Via Rondona, 33 44049 Ferrara
  • 2. AGENDA 09:00. Welcome and Introduction a) Presentation of participants b) Scope of the training c) Agenda for the day 10:00 Technology Overview: Non Destructive Test and Inspection Methods for Parenteral Containers a) CCIT: Vacuum Decay, Pressure Decay, Lid Deflection, Force Decay b) Visual Inspection: Detection of Critical, major and minor defects c) Headspace Gas Analysis: Monitoring Oxygen + Moisture Level & Absolute Pressure in the headspace of sterile parenteral containers 11:00 Regulatory Requirements and Pharmacopeial Updates a) EU, US, Other Countries 12:00. Technology Detail: Each Test and Inspection Method is Detailed a) Principle of operation b) Industry case studies c) Challenge tests d) Validation approach e) Lessons learned 13:00 Lunch Break 14:00. Hands-On: 1. Laboratory: a) How to set-up and run off-line test and inspection systems b) Creation of positive controls and reference standards c) Testing and process validation d) Practical live demonstration 15:30 Lunch Break 16:00. Hands-On: 2. Production Area: a) Analysis of a 100% in-line Headspace Gas Analysis equipment Container Closure Integrity & Visual Inspection Regulations, Theory, Test Methods and Applications of CCI Innovations including Hands-On Activities
  • 3. 2015 PDA Italy Conference, Workshop 2 WAYS TO REGISTER Container Closure Integrity & Visual Inspection Your Contact Person is Gaetano Fiorentino at PDA Italy dt-fiorentino@italfarmaco.com Elena Baccalaro at CCI Italy elena.baccalaro@congressiefiere.com 10 December | Ferrara | Italy 1 ONLINE: https://www.pda-it.org/TR65 2 4 1 ONLINE: https://www.pda-it.org/CCI EMAIL: elena.baccalaro@congressiefiere.com EMAIL: dt-fiorentino@italfarmaco.com ThisPDF-fileprovidesanautomatic fill-in function. Your signature, however, is needed in writing. 1Your Contact Information Ifthisformisanupdatetoapreviouslysubmittedform,pleasecheckhere. Mr. Ms. Dr. Nonmember IwanttobecomeaPDAMember. Please sendme asubscriptionform Name(Last, First, MI)* PDA Member IDNumber Job Title* Company* Department Mailing Address City Postal Code Country Email * Business Phone Fax Substituting for (Check only if you are substituting for a previously enrolled colleague; a nonmember substituting for member must pay the membership fee.) Registration No PDA membership included 3 Payment All fees given in Euro andexcluding VAT Conference (10December) PDA Member Nonmember 395 By Bank Transfer beneficiary: PDAItaly Chapter IBAN: IT55T0103071940000002767926 BIC: PASCITMMPOG Bank Address: BancaMontedeiPaschidiSiena,AgenziadiPoggibonsi,Loc.Salceto,95–53036 Poggibonsi(SI) The fee includes course documentation as well as mid-session refreshments and lunch. Excellent networking opportunities with snacks and drinks will be given. The fee does not include the hotel accommodation. PDA Italy has secured a limited number of rooms at a special group rate. Group Registration Discount Register 5 colleagues for the con- ference at the same time and receive the 5th registration free. For more information on group discounts please contact Gaetano Fiorentino at dt-fiorentino@italfarmaco.com Other discounts cannot be applied. DiscountforExhibitingCompanies Pleasemarkhereifyourcompanyisanexhibitortothiseventand you will receive the conference ticket at the special price of 800 Euro per ticket. No further discounts are applicablewiththisoption(asPDAMembershipDiscountorGroupTicketdiscount).Thisspecialratedoesnot include one-year PDA membership. Date Mandatory Signature CONFIRMATION: Transmitting your filled-in registration form constitutes a binding application for the specific event. PDA Europe will send you a confirmation including payment details. A legally binding contract is concluded once PDA Europe has sent a written invoice by mail to you. You must have a written confirmation (including invoice) to be considered enrolled in a PDA event. Please allow one week for receipt of confirmation letter. Payment must be received orguaranteed byPurchase Order or credit card details on 1st dayofevent, atthe very latest. SUBSTITUTIONS: Ifyou areunable to attend, substitutions arewelcome and can be made atanytime, including onsite at the prevailing rate. If you are registering as a substitute attendee, please indicate this on the registration form. Changes are free of charge until prior to the start of the event. REFUNDS: Refund requests must be sent to PDA ITALY. If your written request is received on or before 16 October 2015, you will receive a full refund minus a 150 € excl. VAT handling fee. After that time, no refund or credit requests will be approved. If you are an unpaid registrant and do not attend the event, you are responsible for paying the registration fee. On-site registrants are not guaranteed to receive conference materials until alladvanced registered attendees receivethem.PDAItaly worksPCI-Compliant.EVENTCANCELLATION:PDAreservestherighttomodifythematerialorspeakers/instructorswithoutnotice,ortocancelanevent. Ifanevent must be canceled, registrants will be notified byPDAassoon as possible andwill receive afull refund. PDAwill not be responsible for airfare penalties or othercosts incurred duetocancellation. For more details,contact PDAatinfo-Italy@pda.org DOCUMENTATION: With your signature you give complete picture usage right toPDAand allow to film your exhibition space and intervention inthe event, including the recording ofyour presentationfor videopurposes (withyourslides,voice andimage).This rightextends alsototheuseoftheresultingimagesinfilmdocumentationforwebinarsandsimilaritemsproducedbyPDA. www.pda-it.org/CCI 2 4 Location Headquarters Bonfiglioli Engineering via Rondona, 33 44049 - Vigarano Pieve (FE) Italy +39 0532 715 631 +39 0532 715 625 Servizio di navetta da e per la stazione di Bologna
  • 4. Container Closure Integrity & Visual Inspection 10 December - Ferrara MAKING IT EASIER FOR BOTH OF US Ifuncertain aboutyour member IDnumberand/oryourmembershipstatus,call or @Mr. Gaetano Fiorentino. +39 02 6443-3435 dt-fiorentino@italfarmaco.com Pleasewaituntilwesendourinvoicetoyou. It is helpful to reference our invoice numberin your bank transfer details. Pleasenotetheregistrationandcancellationpoliciesatthebottomoftheform. RegistrationcannotbecompletedbysendingPurchaseOrderalone.APurchaseOrderisonlyacceptedifa complete registration form is enclosed or follows very soon. This is particularly important if billing address and site address are different. Contact your accounting depart- ment for correct address and company name. There could be special requirements for accounting. Changesin the billing address (if induced by participating company) will be charged-prior to the startoftheevent. Bank transfers are confirmed upon receipt of full payment. Refunds to bank accounts can be done if payment had been done by bank transfer and the following details areprovided: a) Name of your bank b) IBAN number c) Swift/BIC code Ifaparticipantisunable to attend,substitutionsarewelcomeatanytime.Changesarefreeofchargeuntil priortothestartoftheevent. Tel: +39 02 6443-3435 Email: dt-fiorentino@italfarmaco.com Tel: +39 011 2 4 4 6 9 1 5 Email: Elena.baccalaro@centrocongressiefiere.com T HAN K YO U FOR YOUR COOPERATION! 10 For assistance contact: Elena Baccalaro Executive Manager Centro Congressi Internazionale Italy 9 For assistance contact: Gaetano Fiorentino, President PDA Italy 8 Substitutions 7 Refund/Credit Notes 6 Confirmation of your registration 5 Please state the correct billing address on the registration form 4 Purchase Orders 3 Complete and sign the event registration form 2 Do not send money in advance 1 Please include your member ID number on registration form if available/known www.pda-it.org/CCI