Sterilization Services

Mod­u­lar ster­il­iza­tion and micro­bi­o­log­i­cal mon­i­tor­ing ser­vices from Früh Verpackungstechnik.

Spe­cial­ized ster­il­iza­tion exper­tise avail­able as need­ed. Ensure your process­es com­ply with reg­u­la­tions, com­pen­sate for resource short­ages in a tar­get­ed man­ner, and safe­guard your oper­a­tional flex­i­bil­i­ty.
Früh Ver­pack­ung­stech­nik is your part­ner for mod­u­lar ster­il­iza­tion and micro­bi­o­log­i­cal mon­i­tor­ing ser­vices – indi­vid­u­al­ly com­bin­able and tai­lored pre­cise­ly to your requirements.

Why we offer this ser­vice
The require­ments asso­ci­at­ed with ster­il­iza­tion-relat­ed process­es and micro­bi­o­log­i­cal mon­i­tor­ing are con­tin­u­al­ly increas­ing. At the same time, there is a grow­ing demand for qual­i­fied resources. In order to strate­gi­cal­ly con­front this trend, FRÜH Ver­pack­ung­stech­nik has estab­lished a mod­u­lar ser­vice offer­ing that can be com­bined as need­ed and pro­vides sup­port pre­cise­ly in areas where addi­tion­al exper­tise and capac­i­ty are needed.

How we sup­port you
Eval­u­a­tion of the cor­rect ster­il­iza­tion pro­ce­dure as a sound basis for fur­ther process design. Struc­tured project plan­ning with clear­ly defined time­lines and mile­stones cre­ates trans­paren­cy when it comes to required quan­ti­ties, process steps, and time win­dows.
Plan­ning and com­ple­tion of dose map­pings, dose audits, and ster­il­iza­tion val­i­da­tions includ­ing inspec­tion- and audit-ready doc­u­men­ta­tion that com­plies with the rel­e­vant stan­dards. 
Sup­port­ing reval­i­da­tions with the goal of opti­miz­ing load­ing con­cepts, design­ing process­es more effi­cient­ly, and increas­ing process effi­cien­cy and prod­uct prof­itabil­i­ty over the long term.

Our ser­vices at a glance

1) Micro­bi­o­log­i­cal mon­i­tor­ing and endo­tox­in testing

Devel­op­ment and estab­lish­ment of a resilient micro­bi­o­log­i­cal con­trol sys­tem, from data col­lec­tion to analysis:

• Biobur­den deter­mi­na­tion and trend analyses
• Iden­ti­fi­ca­tion of microorganisms
• Sup­port with devi­a­tion man­age­ment (excur­sions)
• Sup­port with micro­bi­o­log­i­cal risk analyses

2) Val­i­da­tion and reg­u­la­to­ry sup­port for sterilization

• Inspec­tion- and audit-ready doc­u­men­ta­tion that com­plies with the rel­e­vant stan­dards and struc­tured val­i­da­tion strate­gies: Com­plete­ly imple­men­ta­tion-ready val­i­da­tion pack­ages, requal­i­fi­ca­tions, and change impact assessments?
• Stan­dard­ized report­ing for­mats, tech­ni­cal sup­port with audits, and inspec­tions by the authorities

3) Ster­il­iza­tion con­sult­ing and exe­cu­tion support

• Method-spe­cif­ic sup­port with a focus on process reli­a­bil­i­ty and log­ging:
  Val­i­da­tion of radi­a­tion ster­il­iza­tion process­es (gam­ma and x‑ray)
• Dosage deter­mi­na­tion and rou­tine dose audits
• Val­i­da­tion sup­port for steam and EtO sterilization
• Prod­uct pack­ag­ing ser­vice under clean room con­di­tions (ISO 7)

Norms and stan­dards
Our sup­port is aligned with EN 556 – 1:

• EN ISO 11137 (radi­a­tion)
• EN ISO 17665 (steam)
• EN ISO 11135 (EtO)
• ISO 11737- 1 (biobur­den)
• ISO 11737 – 2 (steril­i­ty inspections)
• ISO 11737 – 3 (endo­tox­in)

Why you should choose FRÜH 

• Proven exper­tise in radi­a­tion ster­il­iza­tion and micro­bi­o­log­i­cal control
• Estab­lished, cer­ti­fied part­ner network
• Struc­tured doc­u­men­ta­tion for sup­port­ing reg­u­la­to­ry submissions
• Expe­ri­ence with sup­port­ing audits and inspections

Order­ing and con­tact per­son
For new and repeat ser­vice orders, from now on please use our new order form in the down­load area below.
The PDF form replaces the pre­vi­ous Word doc­u­ment that was sent out.

For spe­cif­ic, tech­ni­cal queries and coor­di­na­tion of the right pro­ce­dure for you, our ster­il­iza­tion experts Alexan­der Müller and Nicole Buch­berg­er are your direct contacts.

You can find all the details in one place here Ser­vice­fly­er Sterilization.