# Sterilization Load Record Template for Medical Device Lots

> Source: https://netray.co/tools/sterilization-load-record-template
> Publisher: Netray (netray.co), AI and integration engineering for ERP and manufacturing systems.
> Section: Free Tools

## Short answer

A load record for sterilization cycles listing load contents, cycle parameters, indicator results and release decision, with signatures.

## Category

quality

## Industry

Medical Devices

## Audience

- Sterilization engineer
- Quality engineer
- Production supervisor

## Tool

**Kind:** template

**Output:** document

**Fields:**

#### Facility

**Key:** company

**Type:** text

**Default:** Meridian Orthopedics Inc., Sterilization Suite

#### Load number

**Key:** load_no

**Type:** text

**Default:** SL-2610-044

#### Sterilization method

**Key:** method

**Type:** select

**Options:**

- Ethylene oxide
- Moist heat (steam)
- Gamma radiation
- Electron beam
- Vaporized hydrogen peroxide

**Default:** Moist heat (steam)

#### Chamber or sterilizer ID

**Key:** chamber

**Type:** text

**Default:** Autoclave AC-02

#### Validated cycle name

**Key:** cycle

**Type:** text

**Default:** Cycle 3, 121 C for 30 min, validation PV-2025-031

#### Product lots in load

**Key:** lots

**Type:** textarea

**Default:** Lot L2610-0417, 492 pouches
Lot L2610-0422, 300 pouches

#### Biological indicator lot and placement

**Key:** bi

**Type:** text

**Default:** BI lot 5518, 3 in load at worst case positions plus 1 positive control

#### Run date

**Key:** date

**Type:** date

**Default:** 2026-10-16

#### Recorded cycle results

**Key:** params

**Type:** textarea

**Default:** Peak temperature 122.4 C, exposure time 30 min, pressure within limits, no alarms. Chart recorder printout attached.

#### Load disposition

**Key:** decision

**Type:** select

**Options:**

- Release
- Hold pending BI result
- Reject

**Default:** Hold pending BI result

**Blocks:**

#### Sterilization Load Record {{load_no}}

**Body:** Facility: {{company}}
Method: {{method}}
Sterilizer: {{chamber}}
Validated cycle: {{cycle}}
Run date: {{date}}

#### Load contents

**Body:** {{lots}}

#### Load configuration

**Table:**

**Columns:**

- Item
- Requirement
- Result

**Rows:**

**0:** Load pattern matches validated pattern

**1:** Yes

**0:** Packaging intact and labeled

**1:** Yes

**0:** Chemical indicator on each tray or pallet

**1:** Changed color

**0:** Product in qualified quantity range

**1:** Yes

#### Cycle record

**Body:** {{params}}

#### Indicators

**Body:** {{bi}}

#### Indicator results

**Table:**

**Columns:**

- Indicator
- Location
- Result
- Read by
- Date

**Rows:**

**0:** Biological indicator 1

**0:** Biological indicator 2

**0:** Positive control

**0:** Chemical indicator

#### Disposition

**Body:** Load disposition: {{decision}}

#### Approvals

**Signatures:**

- Sterilizer operator
- Quality assurance reviewer
- Authorized releaser

**Notes:** Starting point only, not legal advice. Tailor fields to your validated process and to the standards that apply to it, such as ISO 11135 for ethylene oxide, ISO 17665 for moist heat or ISO 11137 for radiation. Parameters must match the validated cycle.

## Content

**Intro:** A sterilization load record shows that a specific load went through a validated cycle and met release criteria. This template captures the load contents, cycle data, indicator results and disposition in one document.

**Sections:**

#### How to use this template

**Body:** Enter the load number, method, sterilizer and validated cycle, list every product lot in the load, and note the biological indicator details. After the cycle, paste or summarize the recorded parameters and attach the chart or printout. Export to PDF or Word, fill in the indicator results and sign. Do not release product until every release criterion in the validated procedure is met.

**Bullets:**

- Match load pattern to the validated configuration
- List every lot so a failure can be traced back
- Attach original cycle printouts or electronic data
- Record who read the biological indicators and when

#### The standards behind the record

**Body:** ISO 13485 clause 7.5.7 requires validation of sterilization processes and records of the results. Each method has its own standard: ISO 11135 for ethylene oxide, ISO 17665 for moist heat, and the ISO 11137 series for radiation. These describe validation, routine control and release. The load record is the routine control evidence that a given load ran within the validated limits and that the product can be released.

#### Release and indicators

**Body:** Product release depends on your validated approach. Many ethylene oxide and steam loads wait for biological indicator incubation results, while some processes use parametric release based on cycle data once the process is shown to be reliable. Chemical indicators show exposure but do not prove sterility. A positive biological indicator in the load triggers a nonconformance and an investigation, and the load is held or rejected.

#### Common mistakes

**Body:** Common problems are loads built differently from the validated pattern, missing lot numbers on the record, indicators read late or not signed, and release before incubation finishes. Another is ignoring changes in packaging or product density that may require requalification. Keep the sterilizer calibration and maintenance current, because a drift in sensors can invalidate every load run since the last good check.

**Cta:** If lots, work orders and release status live in your ERP or MES, Netray can help link sterilization loads to lot status on your own infrastructure, with a person approving each release.

**Faq:**

#### What must a sterilization load record contain?

**Answer:** At minimum the load identity, product lots, method and validated cycle, recorded cycle parameters, indicator results, deviations, disposition and signatures. Your validated procedure may add items such as chamber conditions or pre-conditioning data.

#### Can product be released before the biological indicator result?

**Answer:** Only if your validated process allows it, for example parametric release. Otherwise the load is held until the biological indicators incubate and read negative with a valid positive control.

#### Is a chemical indicator enough?

**Answer:** No. It shows the item was exposed to a process condition, not that sterility was achieved. Biological indicators and recorded cycle parameters provide the main evidence for release.

#### When must a sterilization process be requalified?

**Answer:** Periodically per your procedure, and after changes to equipment, load configuration, packaging, product or bioburden. Each change needs a documented assessment that decides how much requalification is needed.

## Search terms

sterilization load record template, sterilization batch record, ethylene oxide load record, steam sterilization cycle record template, ISO 11135 load release, sterilization log medical device, biological indicator record, parametric release record

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